Application 076342
- Type
- ANDA
- Sponsor
- ANI PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 5MG;6.25MG | No | No |
| 002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 10MG;12.5MG | No | No |
| 003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 20MG;12.5MG | No | No |
| 004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 20MG;25MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 62559-414 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-415 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-416 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-417 | Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | ANI Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8895 | ORIG | 2004-02-12 |