Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 020328
Company: ORGANON USA INC
Company: ORGANON USA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HUMEGON | MENOTROPINS (FSH;LH) | 75 IU/VIAL;75 IU/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
HUMEGON | MENOTROPINS (FSH;LH) | 150 IU/VIAL;150 IU/VIAL | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
09/01/1994 | ORIG-1 | Approval | N/A |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/23/1999 | SUPPL-4 | Supplement |
Label is not available on this site. |
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04/02/1999 | SUPPL-3 | Supplement |
Label is not available on this site. |
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02/21/1997 | SUPPL-2 | Supplement |
Label is not available on this site. |
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07/06/1995 | SUPPL-1 | Supplement |
Label is not available on this site. |