Application 061212
- Type
- ANDA
- Sponsor
- PERRIGO CO TENNESSEE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BACITRACIN | BACITRACIN | OINTMENT;OPHTHALMIC | 500 UNITS/GM | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0574-4022 | Bacitracin | Bacitracin | Paddock Laboratories, LLC | ANDA | Current |
| 0574-4022 | Bacitracin | Bacitracin | Padagis US LLC | ANDA | Current |
| 0574-4022 | Bacitracin | Bacitracin | Padagis US LLC | ANDA | Current |
| 0574-4022 | Bacitracin | Bacitracin | Paddock Laboratories, LLC | ANDA | Current |
| 42254-003 | BACITRACIN | BACITRACIN | Rebel Distributors Corp | ANDA | Current |
| 69784-880 | BACIGUENT | Bacitracin | Woodward Pharma Services LLC | ANDA | Current |
| 69784-880 | BACIGUENT | Bacitracin | Woodward Pharma Services LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 73849 | SUPPL | 2023-03-24 |
| 73848 | SUPPL | 2023-03-24 |
| 73847 | SUPPL | 2023-03-24 |
| 73846 | SUPPL | 2023-03-24 |
| 73845 | SUPPL | 2023-03-24 |
| 73844 | SUPPL | 2023-03-24 |
| 73843 | SUPPL | 2023-03-24 |
| 73842 | SUPPL | 2023-03-24 |
| 57671 | ORIG | 2019-02-15 |