Application 077215
- Type
- ANDA
- Sponsor
- CIPLA
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | CAPSULE;ORAL | EQ 2.5MG BASE;10MG | No | No |
| 002 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | CAPSULE;ORAL | EQ 5MG BASE;10MG | No | No |
| 003 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | CAPSULE;ORAL | EQ 5MG BASE;20MG | No | No |
| 004 | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG BASE;20MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69097-143 | Amlodipine besylate and Benazepril hydrochloride | Amlodipine besylate and Benazepril hydrochloride | Cipla USA Inc. | ANDA | Current |
| 69097-144 | Amlodipine besylate and Benazepril hydrochloride | Amlodipine besylate and Benazepril hydrochloride | Cipla USA Inc. | ANDA | Current |
| 69097-145 | Amlodipine besylate and Benazepril hydrochloride | Amlodipine besylate and Benazepril hydrochloride | Cipla USA Inc. | ANDA | Current |
| 69097-146 | Amlodipine besylate and Benazepril hydrochloride | Amlodipine besylate and Benazepril hydrochloride | Cipla USA Inc. | ANDA | Current |