Application 075967
- Type
- ANDA
- Sponsor
- SUN PHARM INDS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 500MG | No | No |
| 002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 850MG | No | No |
| 003 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 1GM | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 21695-471 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Rebel Distributors Corp. | ANDA | Current |
| 21695-472 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Rebel Distributors Corp. | ANDA | Current |
| 21695-473 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Rebel Distributors Corp. | ANDA | Current |
| 33261-145 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-157 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 50090-0771 | Metformin Hydrochloride | Metformin Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0771 | Metformin Hydrochloride | Metformin Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0777 | Metformin Hydrochloride | Metformin Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 51138-074 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Med-Health Pharma, LLC | ANDA | Current |
| 51138-075 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Med-Health Pharma, LLC | ANDA | Current |
| 51138-076 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Med-Health Pharma, LLC | ANDA | Current |
| 51655-549 | Metformin Hydrochloride | Metformin Hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 53808-0713 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0718 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0720 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 57664-397 | Metformin Hydrochloride | Metformin Hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-435 | Metformin Hydrochloride | Metformin Hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-474 | Metformin Hydrochloride | Metformin Hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63629-1397 | Metformin Hydrochloride | Metformin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1397 | Metformin Hydrochloride | Metformin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 64725-0397 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TYA Pharmaceuticals | ANDA | Current |
| 66267-493 | Metformin Hydrochloride | Metformin Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-493 | Metformin Hydrochloride | Metformin Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 67296-0712 | Metformin Hydrochloride | Metformin Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0712 | Metformin Hydrochloride | Metformin Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0712 | Metformin Hydrochloride | Metformin Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 68788-0397 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-0435 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-0474 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0034 | Metformin Hydrochloride | Metformin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0237 | Metformin Hydrochloride | Metformin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0435 | Metformin Hydrochloride | Metformin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0606 | Metformin Hydrochloride | Metformin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0994 | Metformin Hydrochloride | Metformin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0994 | Metformin Hydrochloride | Metformin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71335-0592 | Metformin Hydrochloride | Metformin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 75921-397 | Metformin Hydrochloride | metformin hydrochloride | Life Line Home Care Services, Inc. | ANDA | Current |