Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012885
Company: LUNDBECK INC
Company: LUNDBECK INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| WINSTROL | STANOZOLOL | 2MG | TABLET;ORAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 01/09/1962 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 11/17/2003 | SUPPL-37 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12885slr037ltr.pdf |
| 02/27/1992 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 12/13/1991 | SUPPL-35 | Labeling |
Label is not available on this site. |
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| 04/07/1994 | SUPPL-34 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/18/1988 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 02/24/1987 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 03/10/1987 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/07/1986 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 05/14/1984 | SUPPL-25 | Efficacy |
Label is not available on this site. |