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FDA Approval Activities for this Drug…
Famotidine Injection, 10 mg/mL, Apotex Corp. ANDA 76-324 11/27/02 Famotidine Injection, 10 mg/mL, Apotex Corp. ANDA 76-322 11/27/02 Famotidine Injection, 10 mg/mL, 4mL & 20 mL vials, Apotex Corp. ANDA 75-942 8/2/02 Famotidine Injection, 10 mg/mL, Abbott ANDA 75-905 11/23/01 4/17/03 Famotidine Injection, 10 mg/mL, Abbott ANDA 75-870 11/23/01 4/17/03 Famotidine Injection, 10 mg/mL, Ben Venue, ANDA 75-825 4/17/01 4/24/01 Famotidine Injection, 10 mg/mL (Preservative-Free), 1/25/2001 Ben Venue, ANDA 75-825 1/25/01 3/5/01 Famotidine Injection, 10 mg/mL, American Pharmaceutical Partners, ANDA 75-813 4/16/01 4/24/01 Famotidine Injection, 10 mg/mL (4 mL and 20 mL Multi-dose vials, Baxter Pharmaceutical Products ANDA 75-799 4/30/02 Famotidine Injection (Preservative Free, 10 mg/mL (2 mL vial, Baxter HealthCare ANDA 75-789 4/30/02 Famotidine Injection, 0.4 mg/mL & 50 mL, Abbott ANDA 75-729 12/17/01 Famotidine Injection, 10 mg/mL & 20 mL, American Pharmaceutical Partners, ANDA 75-709 4/16/01 4/24/01 Famotidine Injection, 10 mg/mL & 20 mL, American Pharmaceutical Partners, ANDA 75-709 2/28/01 3/6/01 Famotidine Injection, 10 mg/mL, Apothecon ANDA 75-708 4/16/01 4/24/01 Famotidine Injection, 10 mg/mL, Apothecon ANDA 75-708 2/7/01 3/6/01 Famotidine Injection, 10 mg/mL, Apothecon ANDA 75-707 4/16/01 4/24/01 Famotidine Injection, 10 mg/mL, Apothecon ANDA 75-707 3/13/01 3/30/01 Famotidine Injection, 10 mg/mL, Faulding Pharmaceutical Co. ANDA 75-705 4/16/01 4/24/01 Famotidine Injection, 10 mg/mL, 12/12/2000 Faulding Pharmaceutical Co. ANDA 75-705 12/12/00 3/5/01 Famotidine Injection, 10 mg/mL, Bedford ANDA 75-684 4/16/01 4/24/01 12/17/01 Famotidine Injection, 10 mg/mL, 1/24/2001 Bedford ANDA 75-684 1/24/01 3/5/01 Famotidine Injection, 10 mg/mL (Preservative-Free), Faulding Pharmaceutical Co. ANDA 75-669 4/16/01 4/24/01 12/17/01 Famotidine Injection, 10 mg/mL (Preservative-Free), 12/12/2000 Faulding Pharmaceutical Co. ANDA 75-669 12/12/00 3/5/01 Famotidine Injection, 10 mg/mL, (Preservative Free), Bedford ANDA 75-651 4/16/01 4/24/01 Famotidine Injection, 10 mg/mL, (Preservative Free), Bedford ANDA 75-622 4/16/01 4/24/01 Famotidine Injection, 10 mg/mL, (Preservative Free), 12/26/2000 Bedford ANDA 75-622 12/26/00 3/5/01 Famotidine Injection, 0.4 mg/mL (20 mg/50 mL), Baxter Healthcare Corp. ANDA 75-591 5/10/01 6/5/01 Famotidine Injection, 10 mg/mL, 4 mL and 20 mL multiple-dose vials (Preserved), ESI Lederle ANDA 75-488 4/16/01 4/24/01 Famotidine Injection, 10 mg/mL, 4 mL and 20 mL multiple-dose vials (Preserved), 12/20/2000 ESI Lederle ANDA 75-488 12/20/00 3/5/01 Famotidine Injection, 10 mg/mL, 2 mL vials (Preservative-Free), ESI Lederle ANDA 75-486 4/16/01 4/24/01 Famotidine Injection, 10 mg/mL, 2 mL vials (Preservative-Free) 12/20/2000 ESI Lederle ANDA 75-486 12/20/00 3/5/01 Famotidine Injection, 10 mg/mL, 2 mL vial (Preservative-Free) 11/20/1998 Marsam ANDA 75-194 11/20/98 11/20/98 Famotidine Injection,10 mg/mL, Pharmacy bulk package (Preservative-Free), Nov. 30, 1998 Marsam ANDA 75-193 11/30/98 12/1/98 Famotidine Injection, 10 mg/mL, 4 mL and 20 mL Multiple-Dose Vials 11/20/1998 Marsam ANDA 75-192 11/20/98 11/20/98 Famotidine Tablets USP, 10 mg, OTC Eon labs ANDA 76-101 10/21/02 Famotidine Tablets USP, 10 mg, Eon labs Manufacturing, ANDA 76-101 9/14/01 4/16/03 Famotidine Tablets USP,20 & 40 mg, Carlsbad Technology ANDA 75-805 4/16/01 4/24/01 Famotidine Tablets USP,20 & 40 mg, Eon Labs Manufacturing, ANDA 75-793 4/16/01 4/24/01 Famotidine Tablets USP, 20 mg and 40 mg, Wockhardt Americas, ANDA 75-786 4/16/01 4/24/01 Famotidine Tablets USP, 20 mg and 40 mg, 3/28/01 Wockhardt Americas, ANDA 75-786 3/28/01 3/30/01 Famotidine Tablets USP, 10 mg, OTC Dr. Reddy's Ltd. ANDA 75-758 8/17/01 Famotidine Tablets USP, 10 mg, OTC 12/13/00 Cheminor Drugs Limited ANDA 75-758 12/13/00 3/5/01 Famotidine Tablets USP,20 mg and 40 mg, 11/29/00 Cheminor Drugs Limited ANDA 75-718 11/29/00 3/5/01 Famotidine Tablets USP,20 mg and 40 mg, Reddy-Cheminor ANDA 75-718 4/16/01 4/24/01 Famotidine Tablets USP,20 mg and 40 mg, 7/27/00 Reddy-Cheminor ANDA 75-718 7/27/00 11/7/00 Famotidine Tablets USP, 10 mg, L.Perrigo Company ANDA 75-715 8/22/03 Famotidine Tablets USP,20 mg and 40 mg, Mylan ANDA 75-704 4/16/01 4/24/01 Famotidine Tablets USP,20 mg and 40 mg, 2/6/2001 Mylan ANDA 75-704 2/6/01 3/5/01 Famotidine Tablets USP, 10 mg, OTC Genpharm ANDA 75-674 12/21/01 Famotidine Tablets USP, 10 mg, OTC Genpharm ANDA 75-674 10/12/01 Famotidine Tablets USP, 20 mg and 40 mg, Purepac Pharmaceutical Co. ANDA 75-650 9/14/01 4/14/03 5/1/02 5/1/02 Famotidine Tablets USP,20 mg and 40 mg, 3/17/2000 Purepac Pharmaceutical Co. ANDA 75-650 3/17/00 3/21/00 Famotidine Tablets USP, 20 mg & 40 mg, Mutual Pharmaceutical Company, ANDA 75-639 12/12/01 Famotidine Tablets USP,20 mg & 40 mg, (tentatively Approved 3/16/00) Apothecon, ANDA 75-628 3/16/00 3/21/00 Famotidine Tablets USP, 10 mg, Torpharm ANDA 75-610 3/12/02 4/10/03 Famotidine Tablets USP, 20 mg and 40 mg, Invamed ANDA 75-607 5/10/01 6/5/01 Famotidine Tablets USP, 20 mg and 40 mg, Torpharm ANDA 75-611 7/23/01 Famotidine Tablets USP, 20 mg and 40 mg, Zenith Goldline ANDA 75-511 4/16/01 4/24/01 Famotidine Tablets USP, 20 mg and 40 mg, February 18, 2000 Zenith Goldline ANDA 75-511 2/18/00 Famotidine Tablets USP, 20 mg & 40 mg, Genpharm ANDA 75-457 4/18/01 4/24/01 Famotidine Tablets USP, 20 mg & 40 mg, 4/26/2000 Genpharm ANDA 75-457 4/26/00 4/28/00 Famotidine Tablets USP, 10 mg, Danbury Pharmacal, ANDA 75-404 11/28/01 4/14/03 Famotidine Tablets USP, 10 mg, Jun. 04, 1999 Danbury Pharmacal, ANDA 75-404 6/4/99 6/11/99 Famotidine Tablets USP, 10 mg, L. Perrigo Co. ANDA 75-400 3/25/02 4/10/03 Famotidine Tablets USP, 10 mg, Teva ANDA 75-312 5/31/01 6/5/01 Famotidine Tablets USP, 10 mg, 10/15/1998 Teva ANDA 75-312 10/15/98 10/26/98 Famotidine Tablets USP, 20 mg and 40 mg, Teva ANDA 75-311 4/16/01 4/24/01 1/3/02 1/3/02 Famotidine Tablets USP, 20 mg and 40 mg, Oct. 15, 1998 Teva ANDA 75-311 10/15/98 10/26/98 Famotidine Tablets USP, 20 mg and 40 mg, Geneva ANDA 75-302 4/16/01 4/24/01 Famotidine Tablets USP, 20 mg and 40 mg, Geneva ANDA 75-302 2/5/01 2/28/01 Famotidine Tablets USP, 20 mg and 40 mg, Geneva ANDA 75-302 8/30/99 9/2/99 Famotidine Tablets USP, 20 mg and 40 mg,Rx Danbury Pharmacal ANDA 75-062 4/16/01 4/24/01 Famotidine Tablets USP, 20 mg and 40 mg,Rx , 10/28/1998 Danbury Pharmacal ANDA 75-062 10/28/98 10/28/98 Famotidine Tablets USP, 20 mg and 40 mg, October 28, 1998 Novopharm Limited ANDA 74-687 10/28/98 10/29/98 Pepcid AC Coated Tablets,10 mg, OTC Merck & Co., Inc NDA 19-462 4/30/03 Pepcid AC Coated Tablets,10 mg, OTC Merck & Co., Inc NDA 19-462/S29 4/25/01 4/23/03 Pepcid Complete Chewable Tablets, Suspension, Orally Disintegrating Tablets Merck & Co., Inc NDA 19-510 11/4/86 4/30/03 Pepcid AC Coated Tablets,10 mg, OTC Merch Research NDA 20-902 8/5/99 5/16/00 Pepcid AC (Famotidine) Tablets, Merck & Co., NDA 20-325/S15 9/23/03 9/30/03 9/30/03 Pepcid AC Film Coated Tablets, Merck & Co., NDA 20-325/S-013 3/1/02 3/5/02 Pepcid AC Film Coated Tablets, Merck & Co., NDA 20-325/S-3 3/1/02 3/6/02 Pepcid AC (famotidine) Chewable Tablets, OTC Merck & Co., NDA 20-801/S-007 1/31/02 3/6/02 Pepcid AC Chewable Tablets, OTC Merck Reseach NDA 20-801/S-004 4/10/01 4/9/03 5/9/03 Pepcid AC (famotidine) Chewable Tablets,OTC Merck Reseach NDA 20-801 9/24/98 9/25/98 9/25/98 3/16/99 Pepcid AC Indications:1) For the relief of heartburn, acid indigestion, and sour stomach. 2) For the prevention of heartburn, acid indigestion, and sour stomach brough on by consuming food and beverages. Pepcid Complete Chewable Tablets, Suspension, Orally Disintegrating Tablets Merck Research NDA 20-958/S2 11/06/01 04/25/03 Pepcid Complete Chewable Tablets, OTC Merck Research NDA 20-958 10/16/00 10/20/00 10/30/00 9/25/03 Pepcid Indication:for use in the relief of heartburn associated with acid indigestion and sour stomach. Pepcid (famotidine) Coated (gelatin coated, capsule shaped) Tablets Merck Research NDA 20-752 8/5/99 8/6/99 8/6/99 Pepcid Indication:1. Treatment of Heartburn associated with acid indigestion and sour stomach 2. Prevention of meal-induced heartburn Pepcid (famotidine) RPD Orally Disintegrating Tablets,20 and 40 mg Merck Research NDA 20-752 5/28/98 6/1/98 6/1/98 Pepcid RPD Indication:This application provides for a new dosage form for prescription pepcid (famotidine) which is indicated for the treatment of ulcers, GERD, and hypersecretory disease (see labeling for details). Pepcid (famotidine) Coated (gelatin coated, capsule shaped) Tablets Merck Research NDA 20-752 8/5/99 Pepcid Indication:1. Treatment of Heartburn associated with acid indigestion and sour stomach 2. Prevention of meal-induced heartburn Pepcid (Famotidine) Tablets, Suspension, Orally Disintegrating Tablets Merck Research NDA 19-462/S31, 19-527/S25, & 20-752/S6 3/14/01 Pepcid (Famotidine) Tablets, Injection, & Suspension, Merck and Co. NDA 19-462/S30, 19-527/S24, & 20-752/S5 6/6/02 6/14/02 6/7/02 Pepcid (Famotidine) Tablets, Injection, & Suspension, Merck Research NDA 19-462/S27, 19-527/S20, & 20-752/S2 3/18/99 7/5/00 Pepcid (Famotidine) Injection & Injection Premixed, Merck Research NDA 19-510/S029 & 20-249/S12 3/14/01 4/27/01 4/27/01 Pepcid (Famotidine) Injection & Injection Premixed, Merck and Co., NDA 19-510/S028 & 20-249/S011 6/6/02 6/14/02 6/7/02 Pepcid (Famotidine) Injection & Injection Premixed, Merck Research NDA 19-510/S026 & 20-249/S09 3/18/99 8/17/99 Pepcid Indications: Short term treatment of active duodenal ulcer. FAMOTIDINE For Suspension; 40MG/5ML PEPCID MERCK 075729 FAMOTIDINE Injection 0.4MG/ML FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER Abbott 075870 FAMOTIDINE Injection 10MG/ML FAMOTIDINE Abbott 075905 FAMOTIDINE Injection 10MG/ML FAMOTIDINE Abbott 075813 FAMOTIDINE Injection 10MG/ML FAMOTIDINE PRESERVATIVE FREE AM PARTNERS 075709 FAMOTIDINE Injection 10MG/ML FAMOTIDINE AM PARTNERS 076322 FAMOTIDINE Injection 10MG/ML FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK) Apotex 076324 FAMOTIDINE Injection 10MG/ML FAMOTIDINE PRESERVATIVE FREE Apotex 075942 FAMOTIDINE Injection 10MG/ML FAMOTIDINE Apotex 075591 FAMOTIDINE Injection 0.4MG/ML FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER Baxter 075486 FAMOTIDINE Injection 10MG/ML FAMOTIDINE PRESERVATIVE FREE Baxter 075488 FAMOTIDINE Injection 10MG/ML FAMOTIDINE Baxter 075789 FAMOTIDINE Injection 10MG/ML FAMOTIDINE PRESERVATIVE FREE Baxter 075799 FAMOTIDINE Injection 10MG/ML FAMOTIDINE Baxter 075622 FAMOTIDINE Injection 10MG/ML FAMOTIDINE PRESERVATIVE FREE Bedford 075651 FAMOTIDINE Injection 10MG/ML FAMOTIDINE Bedford 075684 FAMOTIDINE Injection 10MG/ML FAMOTIDINE Bedford 075825 FAMOTIDINE Injection 10MG/ML FAMOTIDINE PRESERVATIVE FREE Ben Venue 075669 FAMOTIDINE Injection 10MG/ML FAMOTIDINE PRESERVATIVE FREE Faulding 075705 FAMOTIDINE Injection 10MG/ML FAMOTIDINE Faulding 020249 FAMOTIDINE Injection 0.4MG/ML PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER MERCK 019510 FAMOTIDINE Injection 10MG/ML PEPCID MERCK 019510 FAMOTIDINE Injection 10MG/ML PEPCID PRESERVATIVE FREE MERCK 075805 FAMOTIDINE Tablet; 20MG FAMOTIDINE CARLSBAD 075805 FAMOTIDINE Tablet; 40MG FAMOTIDINE CARLSBAD 075718 FAMOTIDINE Tablet; 20MG FAMOTIDINE DR REDDYS LTD 075718 FAMOTIDINE Tablet; 40MG FAMOTIDINE DR REDDYS LTD 075793 FAMOTIDINE Tablet; 20MG FAMOTIDINE Eon 075793 FAMOTIDINE Tablet; 40MG FAMOTIDINE Eon 075302 FAMOTIDINE Tablet; 20MG FAMOTIDINE Geneva 075302 FAMOTIDINE Tablet; 40MG FAMOTIDINE Geneva 075457 FAMOTIDINE Tablet; 20MG FAMOTIDINE Genpharm 075457 FAMOTIDINE Tablet; 40MG FAMOTIDINE Genpharm 075607 FAMOTIDINE Tablet; 20MG FAMOTIDINE INVAMED 075607 FAMOTIDINE Tablet; 40MG FAMOTIDINE INVAMED 075511 FAMOTIDINE Tablet; 20MG FAMOTIDINE Ivax 075511 FAMOTIDINE Tablet; 40MG FAMOTIDINE Ivax 019462 FAMOTIDINE Tablet; 20MG PEPCID MERCK 019462 FAMOTIDINE Tablet; 40MG PEPCID MERCK 075639 FAMOTIDINE Tablet; 20MG FAMOTIDINE Mutual 075639 FAMOTIDINE Tablet; 40MG FAMOTIDINE Mutual 075704 FAMOTIDINE Tablet; 20MG FAMOTIDINE Mylan 075704 FAMOTIDINE Tablet; 40MG FAMOTIDINE Mylan 075650 FAMOTIDINE Tablet; 20MG FAMOTIDINE Purepac 075650 FAMOTIDINE Tablet; 40MG FAMOTIDINE Purepac 075311 FAMOTIDINE Tablet; 20MG FAMOTIDINE Teva 075311 FAMOTIDINE Tablet; 40MG FAMOTIDINE Teva 075611 FAMOTIDINE Tablet; 20MG FAMOTIDINE Torpharm 075611 FAMOTIDINE Tablet; 40MG FAMOTIDINE Torpharm 075062 FAMOTIDINE Tablet; 20MG FAMOTIDINE Watson 075062 FAMOTIDINE Tablet; 40MG FAMOTIDINE Watson 075786 FAMOTIDINE Tablet; 20MG FAMOTIDINE Wockhardt 075786 FAMOTIDINE Tablet; 40MG FAMOTIDINE Wockhardt Pepcid Complete Tablets, Merck Famotidine Tablets USP, Teva Pharmaceuticals | Fluxid (famotidine orally disintegrating tablets), Schwarz Pharma, Approval | Pepcid AC Film Coated (famotidine) Tablets, Merck Research, Labeling Revision | Pepcid AC Chewable (famotidine) Tablets, Merck Research, Labeling Revision | Pepcid AC Gelcaps (famotidine) Capsules, Merck Research, Labeling Revision | Pepcid Complete Tablets, Merck Research, Labeling Revision | Pepcid (famotidine) Oral Suspension, Merck & Co., Labeling Revision | Famotidine Tablets, Wockhardt, Approval | Famotidine Tablets, L. Perrigo Co., Approval | Pepcid Complete chewable tablets, Merck, Labeling Revision | Famotidine Tablets, Perrigo, Approval | Famotidine Tablets, Dr. Reddy's Labs, Tentative Approval | Famotidine Tablets, Perrigo R&D, Tentative Approval | Pepcid AC (famotidine) tablets, Merck & Co., Labeling Revision | Pepcid AC Gelcaps (famotidine) capsules , Merck & Co., Labeling Revision | Pepcid Complete tablets, Merck & Co., Labeling Revision | Famotidine Tablets, Perrigo R&D, Approval | Famotidine Tablets, Dr. Reddy’s Labs, Approval
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