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Application 212280
- Type
- ANDA
- Sponsor
- CIPLA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 25MG | No | No |
| 002 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 50MG | No | No |
| 003 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 75MG | No | No |
| 004 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 100MG | No | No |
| 005 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 150MG | No | No |
| 006 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 200MG | No | No |
| 007 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 225MG | No | No |
| 008 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 300MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-5938 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | A-S Medication Solutions | ANDA | Current |
| 69097-677 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-677 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-677 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-677 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-678 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-678 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-678 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-678 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-679 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-679 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-679 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-679 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-681 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-681 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-681 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-681 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-682 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-682 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-682 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-682 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-683 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-683 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-683 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-683 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-684 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-684 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-684 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-684 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-685 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-685 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-685 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |
| 69097-685 | PREGABALIN capsules, CV | PREGABALIN capsules, CV | Cipla USA Inc. | ANDA | Current |