Application 090422
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 45MG BASE | No | No |
| 002 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 90MG BASE | No | No |
| 003 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 135MG BASE | No | Yes |
| 004 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | EQ 65MG BASE | No | No |
| 005 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | EQ 115MG BASE | No | No |
| 006 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | EQ 55MG BASE | No | No |
| 007 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | Tablet, Extended Release; Oral | EQ 80MG BASE | No | No |
| 008 | 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 |
|---|---|---|---|---|---|
| 0781-5385 | Minocycline Hydrochloride | Minocycline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-5385 | Minocycline Hydrochloride | Minocycline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-5386 | Minocycline Hydrochloride | Minocycline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-5386 | Minocycline Hydrochloride | Minocycline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-5387 | Minocycline Hydrochloride | Minocycline Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-5387 | Minocycline Hydrochloride | Minocycline Hydrochloride | Sandoz Inc | ANDA | Current |