Application 202768
- Type
- ANDA
- Sponsor
- NATCO PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ARMODAFINIL | ARMODAFINIL | TABLET;ORAL | 50MG | No | No |
| 002 | ARMODAFINIL | ARMODAFINIL | TABLET;ORAL | 150MG | No | No |
| 003 | ARMODAFINIL | ARMODAFINIL | TABLET;ORAL | 250MG | No | No |
| 004 | ARMODAFINIL | ARMODAFINIL | TABLET;ORAL | 100MG | No | No |
| 005 | ARMODAFINIL | ARMODAFINIL | TABLET;ORAL | 200MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51991-322 | Armodafinil | Armodafinil | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-323 | Armodafinil | Armodafinil | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-324 | Armodafinil | Armodafinil | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 10104 | ORIG | 2014-10-21 |