Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018361
Company: EMD SERONO
Company: EMD SERONO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SEROPHENE | CLOMIPHENE CITRATE | 50MG | TABLET;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 |
---|---|---|---|---|---|---|---|
03/22/1982 | 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 |
---|---|---|---|---|---|
07/31/2003 | SUPPL-29 | Labeling |
Label is not available on this site. |
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08/13/2002 | SUPPL-28 | Labeling |
Label is not available on this site. |
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08/14/2001 | SUPPL-27 | Labeling |
Label is not available on this site. |
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02/01/2001 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/02/1996 | SUPPL-24 | Labeling |
Label is not available on this site. |
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12/30/1994 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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08/21/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |