Application 090372
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZAFIRLUKAST | ZAFIRLUKAST | TABLET;ORAL | 10MG | No | No |
| 002 | ZAFIRLUKAST | ZAFIRLUKAST | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50268-805 | Zafirlukast | Zafirlukast | AvPAK | ANDA | Current |
| 50268-805 | Zafirlukast | Zafirlukast | AvPAK | ANDA | Current |
| 50268-805 | Zafirlukast | Zafirlukast | AvPAK | ANDA | Current |
| 55111-625 | Zafirlukast | Zafirlukast | Dr. Reddys Laboratories Limited | ANDA | Current |
| 55111-626 | Zafirlukast | Zafirlukast | Dr. Reddys Laboratories Limited | ANDA | Current |
| 68084-059 | Zafirlukast | Zafirlukast | American Health Packaging | ANDA | Current |
| 68084-059 | Zafirlukast | Zafirlukast | American Health Packaging | ANDA | Current |
| 68084-059 | Zafirlukast | Zafirlukast | American Health Packaging | ANDA | Current |
| 68151-1977 | Zafirlukast | Zafirlukast | Carilion Materials Management | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31463 | ORIG | 2010-11-22 |