Application 075529
- Type
- ANDA
- Sponsor
- PERRIGO PHARMA INTL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TRETINOIN | TRETINOIN | GEL;TOPICAL | 0.025% | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0574-2325 | TRETINOIN | tretinoin | Padagis US LLC | ANDA | Current |
| 0574-2325 | TRETINOIN | tretinoin | Padagis US LLC | ANDA | Current |
| 0574-2325 | TRETINOIN | tretinoin | Paddock Laboratories, LLC | ANDA | Current |
| 0574-2325 | TRETINOIN | tretinoin | Paddock Laboratories, LLC | ANDA | Current |
| 0574-2325 | TRETINOIN | tretinoin | Padagis US LLC | ANDA | Current |
| 21695-763 | Tretinoin | tretinoin | Rebel Distributors Corp | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 43001 | ORIG | 2001-06-07 |
| 8710 | ORIG | 2000-02-22 |