Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020700
Company: VIATRIS
Company: VIATRIS
| 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 | Discontinued | None | Yes | No |
| MUSE | ALPROSTADIL | 0.5MG | SUPPOSITORY;URETHRAL | Discontinued | None | Yes | No |
| MUSE | ALPROSTADIL | 1MG | SUPPOSITORY;URETHRAL | Discontinued | None | Yes | No |
| 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 |