Application 209345
- Type
- ANDA
- Sponsor
- ACTAVIS LABS UT INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PIMECROLIMUS | PIMECROLIMUS | CREAM;TOPICAL | 1% | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0591-2944 | pimecrolimus | pimecrolimus | Actavis Pharma, Inc. | ANDA | Current |
| 70518-2292 | pimecrolimus | pimecrolimus | REMEDYREPACK INC. | ANDA | Current |
| 70518-2292 | pimecrolimus | pimecrolimus | REMEDYREPACK INC. | ANDA | Current |
| 70518-2292 | pimecrolimus | pimecrolimus | REMEDYREPACK INC. | ANDA | Current |
| 70518-2292 | pimecrolimus | pimecrolimus | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 57322 | ORIG | 2019-01-22 |