Application 200142
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACAMPROSATE CALCIUM | ACAMPROSATE CALCIUM | TABLET, DELAYED RELEASE;ORAL | 333MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-6333 | Acamprosate Calcium | acamprosate calcium enteric-coated | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6333 | Acamprosate Calcium | acamprosate calcium enteric-coated | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 51079-241 | Acamprosate Calcium | acamprosate calcium enteric-coated | Mylan Institutional Inc. | ANDA | Current |
| 51079-241 | Acamprosate Calcium | acamprosate calcium enteric-coated | Mylan Institutional Inc. | ANDA | Current |
| 51079-241 | Acamprosate Calcium | acamprosate calcium enteric-coated | Mylan Institutional Inc. | ANDA | Current |