Application 212077
- Type
- ANDA
- Sponsor
- SCIEGEN PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PIRFENIDONE | PIRFENIDONE | CAPSULE;ORAL | 267MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50228-441 | PIRFENIDONE | PIRFENIDONE | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 69097-940 | PIRFENIDONE | PIRFENIDONE | Cipla USA Inc. | ANDA | Current |
| 76282-715 | PIRFENIDONE | PIRFENIDONE | EXELAN PHARMACEUTICALS INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 65858 | ORIG | 2021-01-08 |