Application 076607
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | EQ 5MG BASE | No | No |
| 002 | QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | EQ 10MG BASE | No | No |
| 003 | QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | EQ 20MG BASE | No | No |
| 004 | QUINAPRIL HYDROCHLORIDE | QUINAPRIL HYDROCHLORIDE | TABLET;ORAL | EQ 40MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63304-548 | Quinapril | quinapril | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-549 | Quinapril | quinapril | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-550 | Quinapril | quinapril | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-551 | Quinapril | quinapril | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 8930 | ORIG | 2004-12-30 |