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Application 075504
- Type
- ANDA
- Sponsor
- ANI PHARMS INC
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 |
|---|
| 63629-1241 | Quinapril | Quinapril | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44260 | ORIG | 2007-09-24 |
| 8698 | ORIG | 2003-04-10 |