Application 200744
- Type
- ANDA
- Sponsor
- FOUGERA PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TACROLIMUS | TACROLIMUS | OINTMENT;TOPICAL | 0.03% | No | No |
| 002 | TACROLIMUS | TACROLIMUS | OINTMENT;TOPICAL | 0.1% | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0093-3428 | Tacrolimus | tacrolimus | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-3429 | Tacrolimus | tacrolimus | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0168-0416 | Tacrolimus | tacrolimus | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0416 | Tacrolimus | tacrolimus | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0416 | Tacrolimus | tacrolimus | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0417 | Tacrolimus | tacrolimus | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0417 | Tacrolimus | tacrolimus | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0417 | Tacrolimus | tacrolimus | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 68308-703 | Tacrolimus | tacrolimus | Mayne Pharma Inc. | ANDA | Current |
| 68308-703 | Tacrolimus | tacrolimus | Mayne Pharma Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 58716 | ORIG | 2019-05-15 |
| 9849 | ORIG | 2014-09-10 |