Application 075264
- 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 | 0.025% | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0574-2225 | TRETINOIN | tretinoin | Padagis US LLC | ANDA | Current |
| 0574-2225 | TRETINOIN | tretinoin | Padagis US LLC | ANDA | Current |
| 0574-2225 | TRETINOIN | tretinoin | Paddock Laboratories, LLC | ANDA | Current |
| 0574-2225 | TRETINOIN | tretinoin | Paddock Laboratories, LLC | ANDA | Current |
| 0574-2225 | TRETINOIN | tretinoin | Padagis US LLC | ANDA | Current |
| 21695-655 | Tretinoin | tretinoin | Rebel Distributors Corp | ANDA | Current |
| 43478-243 | Tretinoin | tretinoin | Rouses Point | ANDA | Current |
| 50090-3128 | TRETINOIN | tretinoin | A-S Medication Solutions | ANDA | Current |
| 50090-3128 | TRETINOIN | tretinoin | A-S Medication Solutions | ANDA | Current |
| 53002-8101 | TRETINOIN | tretinoin | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 69329-600 | DERMAWERX ZMT PAK | ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, and TRETINOIN | Patchwerx Labs, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 22450 | ORIG | 2001-08-24 |
| 30825 | ORIG | 1998-12-24 |
| 18399 | ORIG | 1998-12-24 |