|
News for: |
|
You will land on a page at the National Library of Medicine where you can drill down to consumer info, research citations, product labelling, toxicology and more. FindingHealthOnline is the world's leading health-pharma search portal and decision engine. It helps you drill down to very detailed information without interference from commercial sites that now dominate Bing, Google, and Yahoo. Near the top of our pages, you will find a link to content that best matches your query.
|
|
|
FDA Approval Activities for this Drug…
Humalog Mix 75/25, Eli Lilly NDA 21-017/S10 6/22/03 7/28/03 Humalog Mix 75/25, Eli Lilly NDA 21-017 6/30/03 Humalog Mix 50/50 & 75/25, Subcutaneous injection, Eli Lilly NDA 21-018 NDA 21-017 12/22/99 1/3/00 1/3/00 1/3/00 6/19/01 Humalog Mix Indication: Treatment of patients with diabetes mellitus for the control of hyperglycemia. Humalog (insulin lispro [rDNA origin]) Injection, Eli Lilly NDA 20-563/S-041 9/29/03 10/9/03 10/8/03 Humalog (insulin lispro [rDNA origin]) Injection, Eli Lilly NDA 20-563/S-040 6/24/03 7/6/03 7/8/03 Humalog (insulin lispro [rDNA origin]) Injection, Eli Lilly NDA 20-563/S32 4/1/03 4/16/03 4/18/03 Humalog (insulin lispro [rDNA origin]) Injection, Eli Lilly NDA 20-563/S15 1/2/03 3/26/03 Humalog (insulin lispro [rDNA origin]) Injection, Eli Lilly NDA 20-563/S16 1/2/03 1/23/03 Humalog (insulin lispro [rDNA origin]) Injection, Eli Lilly NDA 20-563/S10, 11, 12, & 13 Humulin, Eli Lilly and Co. NDA 20-100/S21 10/23/03 Humulin Mixture 70/30 Injection, Eli Lilly and Co. NDA 19-717/S52 6/22/03 7/6/03 7/8/03 Humulin Mixture 70/30 Injection, Eli Lilly and Co. NDA 19-717/S41 10/3/02 10/11/01 10/4/02 Humulin 70/30 (70% human insulin isophane suspension and 30% human insulin injection, [rDNA origin]). Eli Lilly and Company NDA 19-717/S-030 11/1/02 11/19/02 Humulin L Lente (human insulin [rDNA origin] zinc suspension), Eli Lilly and Company NDA 19-377/S-036 4/18/03 Humulin N, Humulin 70/30 & Humalog, Eli Lilly and Co. NDA 18-781/S-057, 19-717/S-032 & 20-563/S-027 2/12/03 2/25/03 3/11/03 Humulin N (human insulin [rDNA origin]). Eli Lilly and Co. 18-781/S-072 6/22/03 7/6/03 7/8/03 Humulin N (human insulin [rDNA origin]). Eli Lilly and Co. 18-781/S-054 11/5/02 11/19/02 Humulin N/R Mixture 70/30 Injection, Eli Lilly and Co. NDA 19-717/S35 2/3/02 5/16/02 Humulin R (human insulin [rDNA origin] injection) U-500, Eli Lilly and Company NDA 18-780/S-066 4/14/03 Humulin R (human insulin injection, USP, [rDNA origin]), Eli Lilly and Company NDA 18-780/S67 & S78 2/10/03 2/12/03 2/13/03 Humulin U Ultralente (human insulin [rDNA origin] extended zinc suspension), Eli Lilly and Company NDA 19-571/S-029 Iletin I Insulin, Lente Iletin I Insulin, and NPH Iletin I Insulin, respectively. Eli Lilly and Company NDA 17-931/S-025, 17-933/S-026 & 17-936/S-027 Lantus (insulin glargine [rDNA origin] injection), . Aventis NDA 21-081/S5 5/1/03 7/9/03 7/9/03 Lantus (insulin glargine [rDNA origin] injection), . Aventis NDA 21-081 4/20/00 4/24/00 4/24/00 3/18/02 Lantus Indication: is indicated for once-daily subcutaneous administration at bedtime in the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia. Lente Iletin® II Pork (insulin zinc suspension, USP purified pork), Eli Lilly and Company NDA 18-347/S-025 Novolin. L, Lente, (human insulin [rDNA origin] zinc suspension)., Novo Nordisk NDA 19-965/S24 7/25/03 8/15/03 8/15/03 Novolin R, N, & 70/30 (Human Insulin [rDNA Origin & Isophane), Novo Nordisk NDA 19-938/S-033, 19-959/S-035 & 19-991/S-036 4/15/02 4/22/02 4/15/02 Novolin R, N, & 70/30 (Human Insulin [rDNA Origin & Isophane), Novo Nordisk NDA 19-938/S-032, 19-959/S-034 & 19-991/S-035 4/11/02 4/16/02 4/15/02 Novolin R, N, & 70/30 (Human Insulin [rDNA Origin & Isophane), Novo Nordisk NDA 19-938/S-030, 19-959/S-031 & 19-991/S-032 3/11/02 3/29/02 3/18/02 Novolin R, N, & 70/30 (Human Insulin [rDNA Origin & Isophane), Novo Nordisk NDA 19-959/S-36 12/19/01 4/17/03 Novolin R, N, & 70/30 (Human Insulin [rDNA Origin & Isophane), Novo Nordisk NDA 19-991/S-31 12/01/01 4/17/03 Novolin R, N, & 70/30 (Human Insulin [rDNA Origin & Isophane), Novo Nordisk NDA 19-991/S-37 12/19/01 4/17/03 NovoLog Mix 70/30 Injection, Novo Nordisk NDA 21-172/S9 11/18/02 11/22/02 11/19/02 NovoLog Mix 70/30 Injection, Novo Nordisk NDA 21-172/S3 6/26/02 7/2/02 6/26/02 NovoLog Mix 70/30 Injection, Novo Nordisk NDA 21-172/S1 5/3/02 5/9/02 5/6/02 NovoLog Mix 70/30 Injection, Novo Nordisk NDA 21-172 11/1/01 8/29/02 8/29/02 8/29/02 NovoLog Mix Indication(s): Treatment of patients with diabetes mellitus for the control of hyperglycemia NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk NDA 20-986/S11 12/4/02 12/9/02 12/6/02 NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk NDA 20-986/S4 4/11/02 4/16/02 4/15/02 NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk NDA 20-986/S3 12/21/01 7/25/02 7/25/02 7/25/02 NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk NDA 20-986/S2 4/11/02 4/16/02 4/15/02 NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk NDA 20-986 Regular Iletin I Insulin, Lente Iletin I Insulin, and NPH Iletin I Insulin, respectively Eli Lilly and Company NDA 17-931/S-025, 17-933/S-026 & 17-936/S-027 INSULIN ASPART Subcutaneous 100 UNITS/ML NOVOLOG NOVO NORDISK 021172 INSULIN ASPART; INSULIN ASPART PROTAMINE Subcutaneous 30 UNITS/ML;70 UNITS/ML NOVOLOG MIX 70/30 NOVO NORDISK 021081 INSULIN GLARGINE Injection 100 UNITS/ML LANTUS AVENTIS 020563 INSULIN LISPRO Injection 100 UNITS/ML HUMALOG LILLY 020563 INSULIN LISPRO Injection 100 UNITS/ML HUMALOG PEN LILLY 021017 INSULIN LISPRO; INSULIN LISPRO PROTAMINE Injection 25 UNITS/ML;75 UNITS/ML HUMALOG MIX 75/25 LILLY 021018 INSULIN LISPRO; INSULIN LISPRO PROTAMINE Injection 50 UNITS/ML;50 UNITS/ML HUMALOG MIX 50/50 LILLY 018344 INSULIN PURIFIED PORK Injection 500 UNITS/ML ILETIN II LILLY 018780 INSULIN RECOMBINANT HUMAN Injection 500 UNITS/ML HUMULIN R LILLY Humulin R (human insulin [rDNA origin] injection), Eli Lilly and Company Humulin Mixture 70/30 Injection, Eli Lilly and Co. Humalog (insulin lispro [rDNA origin]) Injection, Eli Lilly - Humalog Mix 50/50, Eli Lilly - Humalog Mix 75/25, Eli Lilly - Humulin Mixture 70/30 Injection, Eli Lilly and Co. - Humulin N (human insulin [rDNA origin])., Eli Lilly and Co. Humulin N (human insulin [rDNA origin])., Eli Lilly and Co. Humalog (insulin lispro [rDNA origin]) Injection, Eli Lilly NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk Apidra (insulin glulisine [rDNA origin]) Injection, Aventis Pharmaceutal Inc. Humalog Mix 75/25, Eli Lilly NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk Velosulin BR (buffered regular human insulin [rDNA origin] injection), Novo Nordisk Pharmaceuticals Humalog (insulin lispro [rDNA origin] injection), Eli Lilly NovoLog (insulin aspart [rDNA origin] injection), Novo Nordisk Pharmaceuticals, Labeling Revision Lantus (insulin glargine [rDNA origin] injection), Aventis Pharmaceuticals, Package Change Humulin N (human insulin [rDNA origin] isophane suspension), Eli Lilly, Labeling Revision | NovoLog (insulin aspart [rDNA origin] injection), Novo Nordisk, Labeling Revision | NovoLog Mix 70/30, Novo Nordisk, Labeling Revision | Humulin 70/30 Injection, Eli Lilly, Labeling Revision | Lantus (insulin glargine [rDNA origin] injection), Aventis Pharma, Package Change | Humulin R (human insulin [rDNA origin] injection), Eli Lilly and Co., Control Supplement | Humulin N (human insulin [rDNA origin] isophane suspension), Eli Lilly and Co., Control Supplement | Lantus (insulin glargine [rDNA origin] injection), Aventis Pharma, Formulation Revision | Humalog (insulin lispro [rDNA origin] injection), Eli Lilly and Co., Labeling Revision | NovoLog (insulin aspart [rDNA origin] injection), Novo Nordisk, Patient Population Altered | Levemir (insulin detemir [rDNA origin] injection), Novo Nordisk, Approval | NovoLog Mix 70/30 injection, Novo Nordisk, Labeling Revision | Novolin R (human insulin [rDNA origin] injection), Novo Nordisk, Labeling Revision | NovoLog Mix 70/30 injection, Novo Nordisk, Efficacy Supplement w/Clinical Data | Apidra (insulin glulisine [rDNA origin]) injection, Aventis Pharma, Labeling Revision & Package Change | Humulin L (human insulin [rDNA origin] zinc suspension), Eli Lilly and Co., Labeling Revision | Humulin U (human insulin [rDNA origin] extended zinc suspension), Eli Lilly and Co., Labeling Revision | Pork Regular Iletin II (purified pork insulin injection), Eli Lilly and Co., Labeling Revision | Pork NPH Iletin II (isophane purified pork insulin suspension), Eli Lilly and Co., Labeling Revision | Exubera (Insulin Human [rDNA origin]) Inhalation Powder, Pfizer, Approval | Exubera (Insulin Human [rDNA origin]) Inhalation Powder, Pfizer, Approval| NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk, Manufacturing Change or Addition | NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk, Efficacy Supp. w/Clinical Data
|