Application 020700
- Type
- NDA
- Sponsor
- MYLAN SPECIALITY LP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MUSE | ALPROSTADIL | SUPPOSITORY;URETHRAL | 0.125MG | Yes | Yes |
| 002 | MUSE | ALPROSTADIL | SUPPOSITORY;URETHRAL | 0.25MG | Yes | Yes |
| 003 | MUSE | ALPROSTADIL | SUPPOSITORY;URETHRAL | 0.5MG | Yes | Yes |
| 004 | MUSE | ALPROSTADIL | SUPPOSITORY;URETHRAL | 1MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0037-8110 | MUSE | Alprostadil | Meda Pharmaceuticals Inc. | NDA | Current |
| 0037-8110 | MUSE | Alprostadil | Meda Pharmaceuticals | NDA | Current |
| 0037-8110 | MUSE | Alprostadil | Meda Pharmaceuticals | NDA | Current |
| 0037-8110 | MUSE | Alprostadil | Meda Pharmaceuticals | NDA | Current |
| 0037-8110 | MUSE | Alprostadil | Meda Pharmaceuticals Inc. | NDA | Current |
| 0037-8120 | MUSE | Alprostadil | Meda Pharmaceuticals Inc. | NDA | Current |
| 0037-8120 | MUSE | Alprostadil | Meda Pharmaceuticals Inc. | NDA | Current |
| 0037-8120 | MUSE | Alprostadil | Meda Pharmaceuticals | NDA | Current |
| 0037-8120 | MUSE | Alprostadil | Meda Pharmaceuticals | NDA | Current |
| 0037-8120 | MUSE | Alprostadil | Meda Pharmaceuticals | NDA | Current |
| 0037-8130 | MUSE | Alprostadil | Meda Pharmaceuticals Inc. | NDA | Current |
| 0037-8130 | MUSE | Alprostadil | Meda Pharmaceuticals | NDA | Current |
| 0037-8130 | MUSE | Alprostadil | Meda Pharmaceuticals | NDA | Current |
| 0037-8130 | MUSE | Alprostadil | Meda Pharmaceuticals | NDA | Current |
| 0037-8130 | MUSE | Alprostadil | Meda Pharmaceuticals Inc. | NDA | Current |
| 0037-8140 | MUSE | Alprostadil | Meda Pharmaceuticals Inc. | NDA | Current |
| 0037-8140 | MUSE | Alprostadil | Meda Pharmaceuticals Inc. | NDA | Current |
| 0037-8140 | MUSE | Alprostadil | Meda Pharmaceuticals | NDA | Current |
| 0037-8140 | MUSE | Alprostadil | Meda Pharmaceuticals | NDA | Current |
| 0037-8140 | MUSE | Alprostadil | Meda Pharmaceuticals | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 78516 | SUPPL | 2024-05-20 |
| 78514 | SUPPL | 2024-05-20 |