Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 060400
Company: PAR PHARM
Company: PAR PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SUMYCIN | TETRACYCLINE HYDROCHLORIDE | 125MG/5ML | SUSPENSION;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 06/21/1957 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/30/2004 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/14/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1997 | SUPPL-4 | Labeling |
Label is not available on this site. |