Application 076706
- Type
- ANDA
- Sponsor
- APOTEX
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 |
|---|---|---|---|---|---|
| 0904-5794 | Metformin Hydrochloride Extended Release | metformin hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-5794 | Metformin Hydrochloride Extended Release | metformin hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 50090-2026 | Metformin Hydrochloride | Metformin Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50436-0248 | Metformin Hydrochloride | Metformin Hydrochloride | Unit Dose Services | ANDA | Current |
| 51655-550 | Metformin hydrochloride | Metformin hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 60505-0260 | Metformin Hydrochloride | Metformin Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-0260 | Metformin Hydrochloride | Metformin Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-1329 | Metformin Hydrochloride | Metformin Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-1329 | Metformin Hydrochloride | Metformin Hydrochloride | Apotex Corp. | ANDA | Current |
| 63629-4810 | Metformin Hydrochloride | Metformin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-4810 | Metformin Hydrochloride | Metformin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-6395 | Metformin Hydrochloride | Metformin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71205-372 | Metformin Hydrochloride | Metformin Hydrochloride | Proficient Rx LP | ANDA | Current |