Application 203575
- Type
- ANDA
- Sponsor
- PAR STERILE PRODUCTS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | INJECTABLE;INJECTION | 500MG/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42023-172 | Mycophenolate Mofetil | mycophenolate mofetil | Par Pharmaceutical, Inc. | ANDA | Current |
| 42023-172 | Mycophenolate Mofetil | mycophenolate mofetil | Par Pharmaceutical, Inc. | ANDA | Current |
| 42023-172 | Mycophenolate Mofetil | mycophenolate mofetil | Par Pharmaceutical, Inc. | ANDA | Current |
| 42023-172 | Mycophenolate Mofetil | mycophenolate mofetil | Par Pharmaceutical, Inc. | ANDA | Current |
| 42023-172 | Mycophenolate Mofetil | mycophenolate mofetil | Par Pharmaceutical, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76489 | ORIG | 2023-11-07 |
| 45774 | ORIG | 2016-11-02 |