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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 | Apidra (insulin glulisine [rDNA origin]) Injection, Sanofi-Aventis, New Route of Administration | Lantus (insulin glargine [rDNA origin]) Injection, Sanofi-Aventis, Package Change | Levemir (insulin detemir [rDNA origin] injection), Novo Nordisk, Formulation Revision | Humalog (insulin lispro injection [rDNA origin]) Injection, Eli Lilly, Labeling Revision | Humalog (insulin lispro [rDNA origin]) Injection, Eli Lilly, Labeling Revision | NovoLog Mix 70/30 Injection, Novo Nordisk, Formulation Revision | Humulin R (insulin human [rDNA origin]) Injection, Eli Lilly & Co., Labeling Revision | Humulin N NPH (human insulin [rDNA origin]), Isophane Suspension, Eli Lilly & Co., Labeling Revision | Humulin Mix 70/30 (70% human insulin isophane suspension/30%) Injection, Eli Lilly & Co., Labeling Revision | Humulin Mix 50/50 (50% human insulin isophane suspension/50%) Injection, Eli Lilly & Co., Labeling Revision | Humulin R (insulin human injection, USP [rDNA origin]), Eli Lilly & Co., Labeling Revision | Humulin N NPH (human insulin isophane suspension [rDNA origin]), Eli Lilly & Co., Labeling Revision | Humulin 70/30 (70% human insulin isophane suspension/30% insulin human injection, [rDNA origin]), Eli Lilly & Co., Labeling Revision | Humulin 50/50 (50% human insulin isophane suspension/50% insulin human injection, [rDNA origin]), Eli Lilly & Co., Labeling Revision | Humalog (insulin lispro injection [rDNA origin]), Eli Lilly & Co., Labeling Revision | Humalog (insulin lispro injection [rDNA origin]), Eli Lilly & Co., Package Change | Humalog Mix 75/25 (75% insulin lispro protamine suspension/25% insulin lispro injection [rDNA origin]), Eli Lilly & Co., Labeling Revision | Humalog Mix 75/25 (75% insulin lispro protamine suspension/25% insulin lispro injection [rDNA origin]), Eli Lilly & Co., Package Change | Humalog Mix 50/50 (50% insulin lispro protamine suspension/50% insulin lispro injection [rDNA origin]), Eli Lilly & Co., Labeling Revision | Humalog Mix 50/50 (50% insulin lispro protamine suspension/50% insulin lispro injection [rDNA origin]), Eli Lilly & Co., Package Change | Humulin R (insulin [rDNA origin]) Human Injection, Eli Lilly, Labeling Revision | NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk Inc., Patient Population Altered | Humalog Mix 50/50 (insulin lispro protamine [rDNA origin] and insulin lispro [rDNA origin]) Injection, Eli Lilly and Co., Labeling Revision | NovoLog Mix 50/50 (insulin aspart protamine and insulin aspart) Injectable Suspension, Novo Nordisk, Inc., Approval | Levemir (insulin detemir [rDNA origin]) Injection, Novo Nordisk Inc., Labeling Revision | NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk Inc., Labeling Revision | NovoLog Mix 70/30 (insulin aspart protamine [rDNA origin] and insulin aspart [rDNA origin]) Injection, Novo Nordisk Inc., Labeling Revision | Exubera (insulin [rDNA origin]) Inhalation Powder, Pfizer Inc., Labeling Revision | Exubera (insulin human [rDNA origin]) Inhalation Powder, Labeling Revision | Apidra (insulin glulisine [rDNA origin]) Subcutaneous I.V. Injection, Sanofi-Aventis US, LLC, Patient Population Altered
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