Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 006110
Company: ORTHO MCNEIL PHARM
Company: ORTHO MCNEIL PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIENESTROL | DIENESTROL | 0.01% | CREAM;VAGINAL | 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 |
|---|---|---|---|---|---|---|---|
| 01/09/1947 | 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 |
|---|---|---|---|---|---|
| 12/07/1987 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 04/01/1988 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/26/1986 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-24 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/01/1984 | SUPPL-23 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/09/1983 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/1984 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 07/08/1982 | SUPPL-20 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 07/29/1980 | SUPPL-19 | Efficacy |
Label is not available on this site. |
||
| 04/25/1980 | SUPPL-17 | Efficacy |
Label is not available on this site. |
||
| 04/25/1980 | SUPPL-16 | Efficacy |
Label is not available on this site. |
||
| 06/21/1979 | SUPPL-15 | Efficacy |
Label is not available on this site. |
||
| 04/25/1980 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/11/1978 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 04/17/1978 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/25/1977 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 09/27/1976 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 03/10/1976 | SUPPL-5 | Labeling |
Label is not available on this site. |