Application 202555
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MYCOPHENOLIC ACID | MYCOPHENOLIC ACID | TABLET, DELAYED RELEASE;ORAL | 180MG | No | No |
| 002 | MYCOPHENOLIC ACID | MYCOPHENOLIC ACID | TABLET, DELAYED RELEASE;ORAL | 360MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16729-189 | Mycophenolic Acid | Mycophenolic Acid | Accord Healthcare Inc. | ANDA | Current |
| 16729-189 | Mycophenolic Acid | Mycophenolic Acid | Accord Healthcare Inc. | ANDA | Current |
| 16729-189 | Mycophenolic Acid | Mycophenolic Acid | Accord Healthcare Inc. | ANDA | Current |
| 16729-189 | Mycophenolic Acid | Mycophenolic Acid | Accord Healthcare Inc. | ANDA | Current |
| 16729-261 | Mycophenolic Acid | Mycophenolic Acid | Accord Healthcare Inc. | ANDA | Current |
| 16729-261 | Mycophenolic Acid | Mycophenolic Acid | Accord Healthcare Inc. | ANDA | Current |
| 16729-261 | Mycophenolic Acid | Mycophenolic Acid | Accord Healthcare Inc. | ANDA | Current |
| 16729-261 | Mycophenolic Acid | Mycophenolic Acid | Accord Healthcare Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76493 | ORIG | 2023-11-07 |