Application 075213
- Type
- ANDA
- Sponsor
- PERRIGO PHARMA INTL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TRETINOIN | TRETINOIN | CREAM;TOPICAL | 0.1% | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0574-2201 | TRETINOIN | tretinoin | Padagis US LLC | ANDA | Current |
| 0574-2201 | TRETINOIN | tretinoin | Padagis US LLC | ANDA | Current |
| 0574-2201 | TRETINOIN | tretinoin | Paddock Laboratories, LLC | ANDA | Current |
| 0574-2201 | TRETINOIN | tretinoin | Paddock Laboratories, LLC | ANDA | Current |
| 0574-2201 | TRETINOIN | tretinoin | Padagis US LLC | ANDA | Current |
| 21695-805 | Tretinoin | Tretinoin | Rebel Distributors Corp | ANDA | Current |
| 43478-241 | Tretinoin | tretinoin | Rouses Point | ANDA | Current |
| 50090-2065 | Tretinoin | tretinoin | A-S Medication Solutions | ANDA | Current |
| 50090-3090 | TRETINOIN | tretinoin | A-S Medication Solutions | ANDA | Current |
| 55045-3691 | Tretinoin | tretinoin | Dispensing Solutions, Inc. | ANDA | Current |
| 70518-3233 | TRETINOIN | tretinoin | REMEDYREPACK INC. | ANDA | Current |
| 70518-3233 | TRETINOIN | tretinoin | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 42959 | ORIG | 2001-08-24 |
| 18393 | ORIG | 1998-12-24 |
| 8566 | ORIG | 1998-12-24 |