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  FDA Approval Activities for this Drug…

Videx EC (didanosine) Chewable dispersible buffered tablets, Bristol-Myers Squibb NDA 20-154/S35, S36 9/10/01 4/21/03 Videx EC (didanosine) Chewable dispersible buffered tablets, Bristol-Myers Squibb NDA 20-155/S26 9/10/01 4/21/03 Videx EC (didanosine) Chewable dispersible buffered tablets, Bristol-Myers Squibb NDA 20-155/S27 9/10/01 4/21/03 Videx EC (didanosine) Chewable dispersible buffered tablets, Bristol-Myers Squibb NDA 20-156/S28 9/10/01 4/21/03 Videx EC (didanosine) Chewable dispersible buffered tablets, Bristol-Myers Squibb NDA 20-156/S28 9/10/01 4/21/03 Videx EC (didanosine) Delayed Release Capsules, Bristol-Myers Squibb NDA 21-183/S5/S6 9/26/02 10/2/02 9/27/02 Videx EC (didanosine) Delayed Release Capsules, Bristol-Myers Squibb NDA 21-183/S4 8/5/02 8/12/02 8/5/02 Videx EC (didanosine) Delayed Release Capsules, Bristol-Myers Squibb NDA 21-183/S2 1/29/02 3/6/02 Videx EC (didanosine) Delayed Release Capsules, Bristol-Myers Squibb NDA 21-183/S1 1/28/02 3/6/02 Videx EC, Bristol-Myers Squibb NDA 21-183 10/31/00 1/5/01 Videx EC Indications: in combination with other antiretroviral agents, as indicated for the treatment of HIV-1 infection in adults whose management requires once-daily administration of didanosine or an alternative didanosine formulation. VIDEX (didanosine) Buffered Tablets, Buffered Powder for Solution, & Pediatric Powder, Bristol-Myers Squibb Company NDA 20-154/S-040 & s-041, 20-155/S-030 & S-031, 20-156/S-031 & S-032 9/25/02 10/2/02 9/25/02 VIDEX (didanosine) Buffered Tablets, Buffered Powder for Solution, & Pediatric Powder, & VIDEX® EC (didanosine) Delayed Release Capsules, Bristol-Myers Squibb Company NDA 20-154/S-42, 20-155/S-32, 20-156/S-33 & 21-183/S-7 3/4/03 3/10/03 3/6/03 VIDEX (didanosine) Buffered Tablets, Buffered Powder for Solution, & Pediatric Powder, & VIDEX® EC (didanosine) Delayed Release Capsules, Bristol-Myers Squibb Company NDA 20-154/S-037, 20-155/S-028, 20-156/S-029 & 21-183/S-003 4/1/02 4/8/02 4/2/02 VIDEX (didanosine) chewable/dispersible tablets, Buffered Powder for Solution, and Pediatric Powder for Solution, Bristol-Myers Squibb NDA 20-154/S29, S30 20-155/S21 20-156/S22 DIDANOSINE Capsule, Delayed Rel Pellets; 125MG VIDEX EC BRISTOL MYERS SQUIBB 021183 DIDANOSINE Capsule, Delayed Rel Pellets; 200MG VIDEX EC BRISTOL MYERS SQUIBB 021183 DIDANOSINE Capsule, Delayed Rel Pellets; 250MG VIDEX EC BRISTOL MYERS SQUIBB 021183 DIDANOSINE Capsule, Delayed Rel Pellets; 400MG VIDEX EC BRISTOL MYERS SQUIBB 020155 DIDANOSINE For Solution; 100MG/PACKET VIDEX BRISTOL MYERS SQUIBB 020156 DIDANOSINE For Solution; 10MG/ML VIDEX BRISTOL MYERS SQUIBB 020155 DIDANOSINE For Solution; 167MG/PACKET VIDEX BRISTOL MYERS SQUIBB 020155 DIDANOSINE For Solution; 250MG/PACKET VIDEX BRISTOL MYERS SQUIBB 020154 DIDANOSINE Tablet, Chewable; 100MG VIDEX BRISTOL MYERS SQUIBB 020154 DIDANOSINE Tablet, Chewable; 150MG VIDEX BRISTOL MYERS SQUIBB 020154 DIDANOSINE Tablet, Chewable; 200MG VIDEX BRISTOL MYERS SQUIBB 020154 DIDANOSINE Tablet, Chewable; 25MG VIDEX BRISTOL MYERS SQUIBB 020154 DIDANOSINE Tablet, Chewable; 50MG VIDEX BRISTOL MYERS SQUIBB VIDEX (didanosine) Chewable Tablets, Buffered/Pediatric Powder for Oral Solution, & Delayed-Release Capsules, Bristol-Myers Squibb | Didanosine Tablets, Aurobindo Pharma, Tentative Approval | Videx (didanosine) Buffered Powder for Oral Solution, Bristol-Myers Squibb, Labeling Revision | Videx (didanosine) Chewable/Dispersible Buffered Tablets, Bristol-Myers Squibb, Labeling Revision | Videx (didanosine) Pediatric Powder for Oral Solution, Bristol-Myers Squibb, Labeling Revision | Videx EC (didanosine) Delayed Release Capsules, Bristol-Myers Squibb, Labeling Revision | Didanosine Oral Solution, Aurobindo Pharma, Tentative Approval | Videx (didanosine) Chewable/Dispersible Buffered Tablets, Bristol-Myers Squibb, Labeling Revision | Videx (didanosine) Buffered Powder for Oral Solution, Bristol-Myers Squibb, Labeling Revision | Videx (didanosine) Pediatric Powder for Oral Solution, Bristol-Myers Squibb, Labeling Revision | Videx EC (didanosine) Delayed Release Capsules, Bristol-Myers Squibb, Labeling Revision | Didanosine Oral Solution, Aurobindo Pharma, Approval

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