Application 079013
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALFUZOSIN HYDROCHLORIDE | ALFUZOSIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42291-110 | Alfuzosin Hydrochloride | Alfuzosin Hydrochloride | AvKARE, Inc. | ANDA | Current |
| 60505-2850 | Alfuzosin Hydrochloride | Alfuzosin Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2850 | Alfuzosin Hydrochloride | Alfuzosin Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2850 | Alfuzosin Hydrochloride | Alfuzosin Hydrochloride | Apotex Corp. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31403 | ORIG | 2011-07-20 |