Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 061015
Company: CASPER PHARMA LLC
Company: CASPER PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TERRAMYCIN W/ POLYMYXIN B SULFATE | OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE | EQ 5MG BASE/GM;10,000 UNITS/GM | OINTMENT;OPHTHALMIC | 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 |
|---|---|---|---|---|---|---|---|
| 07/08/1965 | 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 |
|---|---|---|---|---|---|
| 10/25/2004 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/22/2000 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/01/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/06/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/14/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |