Application 203443
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 55MG BASE | No | No |
| 002 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 80MG BASE | No | No |
| 003 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 105MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-4293 | Minocycline Hydrochloride | minocycline hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4293 | Minocycline Hydrochloride | minocycline hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4294 | Minocycline Hydrochloride | minocycline hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4294 | Minocycline Hydrochloride | minocycline hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |