Application 050781
- Type
- NDA
- Sponsor
- ORAPHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ARESTIN | MINOCYCLINE HYDROCHLORIDE | POWDER, EXTENDED RELEASE;DENTAL | EQ 1MG BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65976-100 | Arestin | Minocycline Hydrochloride | OraPharma, Inc. | NDA | Current |
| 65976-100 | Arestin | Minocycline Hydrochloride | OraPharma, Inc. | NDA | Current |
| 65976-100 | Arestin | Minocycline Hydrochloride | OraPharma, Inc. | NDA | Current |
| 65976-100 | Arestin | Minocycline Hydrochloride | OraPharma, Inc. | NDA | Current |
| 65976-100 | Arestin | Minocycline Hydrochloride | OraPharma, Inc. | NDA | Current |