Application 214630
- Type
- ANDA
- Sponsor
- BIOCON PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MYCOPHENOLIC ACID | MYCOPHENOLIC ACID | TABLET, DELAYED RELEASE;ORAL | EQ 180MG BASE | No | No |
| 002 | MYCOPHENOLIC ACID | MYCOPHENOLIC ACID | TABLET, DELAYED RELEASE;ORAL | EQ 360MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70377-039 | Mycophenolic Acid | Mycophenolic Acid | Biocon Pharma Inc. | ANDA | Current |
| 70377-039 | Mycophenolic Acid | Mycophenolic Acid | Biocon Pharma Inc. | ANDA | Current |
| 70377-039 | Mycophenolic Acid | Mycophenolic Acid | Biocon Pharma Inc. | ANDA | Current |
| 70377-040 | Mycophenolic Acid | Mycophenolic Acid | Biocon Pharma Inc. | ANDA | Current |
| 70377-040 | Mycophenolic Acid | Mycophenolic Acid | Biocon Pharma Inc. | ANDA | Current |
| 70377-040 | Mycophenolic Acid | Mycophenolic Acid | Biocon Pharma Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76506 | ORIG | 2023-11-07 |