Application 202306
- Type
- ANDA
- Sponsor
- INTELLIPHARMACEUTICS
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 |
|---|
| 35208-001 | Metformin Hydrochloride | Metformin Hydrochloride | IntelliPharmaCeutics Corp. | ANDA | Current |
| 35208-001 | Metformin Hydrochloride | Metformin Hydrochloride | IntelliPharmaCeutics Corp. | ANDA | Current |
| 35208-002 | Metformin Hydrochloride | Metformin Hydrochloride | IntelliPharmaCeutics Corp. | ANDA | Current |
| 35208-002 | Metformin Hydrochloride | Metformin Hydrochloride | IntelliPharmaCeutics Corp. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 47415 | ORIG | 2017-03-02 |