Drugs@FDA: FDA-Approved Drugs
Company: SHIRE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOPICYCLINE | TETRACYCLINE HYDROCHLORIDE | 2.2MG/ML | FOR SOLUTION;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 09/21/1977 | 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 |
|---|---|---|---|---|---|
| 10/17/1997 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/23/1997 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1986 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 01/17/1983 | SUPPL-28 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/22/1982 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 12/01/1981 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/1981 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 08/10/1981 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1982 | SUPPL-23 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/13/1981 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 02/02/1981 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/20/1980 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/22/1979 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/03/1979 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/1979 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 03/28/1979 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/26/1979 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/10/1978 | SUPPL-14 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/25/1978 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/24/1978 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/24/1978 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/11/1978 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/16/1978 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 01/24/1978 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1978 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/19/1986 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/27/1977 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/24/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |