Application 077336
- Type
- ANDA
- Sponsor
- SUN PHARM INDS (IN)
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 500MG | No | No |
| 002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 750MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0615-7847 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 21695-828 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Rebel Distributors Corp | ANDA | Current |
| 50090-1981 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-2258 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 51655-551 | Metformin HCl ER | Metformin Hydrochloride Extended Release | Northwind Pharmaceuticals | ANDA | Current |
| 53808-0613 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55700-320 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-320 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 62756-142 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-142 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-143 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-143 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63629-2883 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-2883 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 67296-1527 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1527 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1527 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | RedPharm Drug, Inc. | ANDA | Current |
| 68071-1927 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 70518-1606 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1606 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1606 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1606 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1606 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1606 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-3200 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-3200 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70914-000 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Hudson Scientific LLC | ANDA | Current |
| 71335-0140 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0140 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0140 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71610-441 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-447 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-447 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 76413-156 | Metformin hydrochloride | METFORMIN HYDROCHLORIDE | Central Texas Community Health Centers | ANDA | Current |
| 76519-1152 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | H. J. Harkins Company Inc. | ANDA | Current |