Application 075972
- Type
- ANDA
- Sponsor
- CHARTWELL LIFE SCI
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 |
| 004 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 750MG | No | No |
| 005 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 625MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 62135-680 | Metformin Hydrochloride | Metformin Hydrochloride | Chartwell RX, LLC | ANDA | Current |
| 62135-680 | Metformin Hydrochloride | Metformin Hydrochloride | Chartwell RX, LLC | ANDA | Current |
| 62135-681 | Metformin Hydrochloride | Metformin Hydrochloride | Chartwell RX, LLC | ANDA | Current |
| 62135-681 | Metformin Hydrochloride | Metformin Hydrochloride | Chartwell RX, LLC | ANDA | Current |
| 62135-682 | Metformin Hydrochloride | Metformin Hydrochloride | Chartwell RX, LLC | ANDA | Current |
| 62135-682 | Metformin Hydrochloride | Metformin Hydrochloride | Chartwell RX, LLC | ANDA | Current |
| 62135-683 | Metformin Hydrochloride | Metformin Hydrochloride | Chartwell RX, LLC | ANDA | Current |
| 62135-683 | Metformin Hydrochloride | Metformin Hydrochloride | Chartwell RX, LLC | ANDA | Current |
| 62135-684 | Metformin Hydrochloride | Metformin Hydrochloride | Chartwell RX, LLC | ANDA | Current |
| 62135-684 | Metformin Hydrochloride | Metformin Hydrochloride | Chartwell RX, LLC | ANDA | Current |
| 72336-064 | Metformin Hydrochloride | Metformin Hydrochloride | LifSa Drugs, LLC | ANDA | Current |