Application 214629
- Type
- ANDA
- Sponsor
- SCIEGEN PHARMS INC
Application Products#
Product, Drug, Ingredient table| 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 | 1GM | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50228-503 | Metformin Hydrochloride | Metformin Hydrochloride Extended-Release Tablets | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-503 | Metformin Hydrochloride | Metformin Hydrochloride Extended-Release Tablets | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-504 | Metformin Hydrochloride | Metformin Hydrochloride Extended-Release Tablets | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-504 | Metformin Hydrochloride | Metformin Hydrochloride Extended-Release Tablets | ScieGen Pharmaceuticals, Inc. | ANDA | Current |