Application 079118
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
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 | 750MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 57237-210 | Metformin Hydrochloride | Metformin Hydrochloride | Citron Pharma LLC | ANDA | Current |
| 57237-211 | Metformin Hydrochloride | Metformin Hydrochloride | Citron Pharma LLC | ANDA | Current |
| 65862-291 | Metformin Hydrochloride | Metformin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-291 | Metformin Hydrochloride | Metformin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-291 | Metformin Hydrochloride | Metformin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-291 | Metformin Hydrochloride | Metformin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-291 | Metformin Hydrochloride | Metformin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-292 | Metformin Hydrochloride | Metformin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-292 | Metformin Hydrochloride | Metformin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-292 | Metformin Hydrochloride | Metformin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-292 | Metformin Hydrochloride | Metformin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-292 | Metformin Hydrochloride | Metformin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |