Application 090800
- 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 |
|---|
| 62756-310 | Quinapril | Quinapril | Sun Pharmaceutical Industries Limited | ANDA | Current |
| 62756-311 | Quinapril | Quinapril | Sun Pharmaceutical Industries Limited | ANDA | Current |
| 62756-312 | Quinapril | Quinapril | Sun Pharmaceutical Industries Limited | ANDA | Current |
| 62756-313 | Quinapril | Quinapril | Sun Pharmaceutical Industries Limited | ANDA | Current |