Application 200429
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NAPROXEN | NAPROXEN | TABLET;ORAL | 250MG | No | No |
| 002 | NAPROXEN | NAPROXEN | TABLET;ORAL | 375MG | No | No |
| 003 | NAPROXEN | NAPROXEN | TABLET;ORAL | 500MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 57237-214 | Naproxen | Naproxen | Citron Pharma LLC | ANDA | Current |
| 57237-215 | Naproxen | Naproxen | Citron Pharma LLC | ANDA | Current |
| 57237-216 | Naproxen | Naproxen | Citron Pharma LLC | ANDA | Current |
| 65862-520 | Naproxen | Naproxen | Aurobindo Pharma Limited | ANDA | Current |
| 65862-520 | Naproxen | Naproxen | Aurobindo Pharma Limited | ANDA | Current |
| 65862-520 | Naproxen | Naproxen | Aurobindo Pharma Limited | ANDA | Current |
| 65862-520 | Naproxen | Naproxen | Aurobindo Pharma Limited | ANDA | Current |
| 65862-521 | Naproxen | Naproxen | Aurobindo Pharma Limited | ANDA | Current |
| 65862-521 | Naproxen | Naproxen | Aurobindo Pharma Limited | ANDA | Current |
| 65862-521 | Naproxen | Naproxen | Aurobindo Pharma Limited | ANDA | Current |
| 65862-521 | Naproxen | Naproxen | Aurobindo Pharma Limited | ANDA | Current |
| 65862-522 | Naproxen | Naproxen | Aurobindo Pharma Limited | ANDA | Current |
| 65862-522 | Naproxen | Naproxen | Aurobindo Pharma Limited | ANDA | Current |
| 65862-522 | Naproxen | Naproxen | Aurobindo Pharma Limited | ANDA | Current |
| 65862-522 | Naproxen | Naproxen | Aurobindo Pharma Limited | ANDA | Current |
| 80425-0051 | Naprosyn | Naproxen 500mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0051 | Naproxen | Naproxen | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0051 | Naproxen | Naproxen | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |