Application 209993
- Type
- ANDA
- Sponsor
- QINGDAO BAHEAL PHARM
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 |
|---|
| 11788-037 | Metformin Hydrochloride | Metformin Hydrochloride Extended-Release Tablets | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 11788-037 | Metformin Hydrochloride | Metformin Hydrochloride Extended-Release Tablets | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 11788-037 | Metformin Hydrochloride | Metformin Hydrochloride Extended-Release Tablets | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 11788-038 | Metformin Hydrochloride | Metformin Hydrochloride Extended-Release Tablets | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 11788-038 | Metformin Hydrochloride | Metformin Hydrochloride Extended-Release Tablets | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 11788-038 | Metformin Hydrochloride | Metformin Hydrochloride Extended-Release Tablets | AiPing Pharmaceutical, Inc. | ANDA | Current |
| 42806-405 | metformin hydrochloride | metformin hydrochloride tablets | EPIC PHARMA, LLC | ANDA | Current |
| 42806-405 | metformin hydrochloride | metformin hydrochloride tablets | EPIC PHARMA, LLC | ANDA | Current |
| 42806-406 | metformin hydrochloride | metformin hydrochloride tablet | EPIC PHARMA, LLC | ANDA | Current |
| 42806-406 | metformin hydrochloride | metformin hydrochloride tablet | EPIC PHARMA, LLC | ANDA | Current |
| 70247-018 | Metformin Hydrochloride | Metformin Hydrochloride Extended-Release Tablets | Qingdao BAHEAL Pharmaceutical Co., Ltd. | ANDA | Current |
| 70247-018 | Metformin Hydrochloride | Metformin Hydrochloride Extended-Release Tablets | Qingdao BAHEAL Pharmaceutical Co., Ltd. | ANDA | Current |
| 70247-019 | Metformin Hydrochloride | Metformin Hydrochloride Extended-Release Tablets | Qingdao BAHEAL Pharmaceutical Co., Ltd. | ANDA | Current |
| 70247-019 | Metformin Hydrochloride | Metformin Hydrochloride Extended-Release Tablets | Qingdao BAHEAL Pharmaceutical Co., Ltd. | ANDA | Current |