Skip to content
Application 212680
- Type
- ANDA
- Sponsor
- MICRO LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PIRFENIDONE | PIRFENIDONE | TABLET; ORAL | 267MG | No | No |
| 002 | PIRFENIDONE | PIRFENIDONE | TABLET;ORAL | 801MG | No | No |
| 003 | PIRFENIDONE | PIRFENIDONE | TABLET;ORAL | 534MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42571-335 | Pirfenidone | Pirfenidone | Micro Labs Limited | ANDA | Current |
| 42571-336 | Pirfenidone | Pirfenidone | Micro Labs Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 64404 | ORIG | 2020-08-25 |