Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050653
Company: SCHIFF AND CO
Company: SCHIFF AND CO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACTISITE | TETRACYCLINE HYDROCHLORIDE | 12.7MG/FIBER | FIBER, EXTENDED RELEASE;PERIODONTAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/25/1994 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/16/1995 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |