Drugs@FDA: FDA-Approved Drugs
Company: MYLAN SPECIALITY LP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MUSE | ALPROSTADIL | 0.125MG | SUPPOSITORY;URETHRAL | Discontinued | None | Yes | No |
MUSE | ALPROSTADIL | 0.25MG | SUPPOSITORY;URETHRAL | Prescription | None | Yes | Yes |
MUSE | ALPROSTADIL | 0.5MG | SUPPOSITORY;URETHRAL | Prescription | None | Yes | Yes |
MUSE | ALPROSTADIL | 1MG | SUPPOSITORY;URETHRAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
11/19/1996 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/17/2024 | SUPPL-32 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020700s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020700Orig1s032ltr.pdf | |
07/30/2002 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/04/2002 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/24/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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03/31/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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03/30/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
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09/09/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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09/09/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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09/09/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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01/27/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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05/13/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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02/13/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/17/2024 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020700s032lbl.pdf | |
05/17/2024 | SUPPL-32 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020700s032lbl.pdf | |
05/17/2024 | SUPPL-32 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020700s032lbl.pdf |