Application 040166
- Type
- ANDA
- Sponsor
- WOCKHARDT BIO AG
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACETIC ACID | ACETIC ACID, GLACIAL | SOLUTION/DROPS;OTIC | 2% | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-3020 | ACETIC ACID | Acetic Acid | A-S Medication Solutions | ANDA | Current |
| 50436-4600 | Acetic Acid | Acetic Acid | Unit Dose Services | ANDA | Current |
| 60432-741 | ACETIC ACID | Acetic Acid | Morton Grove Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3304 | Acetic Acid | ACETIC ACID | NuCare Pharmaceuticals,Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22088 | ORIG | 2003-07-30 |