Application 205823
- Type
- ANDA
- Sponsor
- PRINSTON INC
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43547-410 | QUINAPRIL | quinapril | Solco Healthcare US, LLC | ANDA | Current |
| 43547-410 | QUINAPRIL | quinapril | Solco Healthcare US, LLC | ANDA | Current |
| 43547-410 | QUINAPRIL | quinapril | Solco Healthcare US, LLC | ANDA | Current |
| 43547-411 | QUINAPRIL | quinapril | Solco Healthcare US, LLC | ANDA | Current |
| 43547-411 | QUINAPRIL | quinapril | Solco Healthcare US, LLC | ANDA | Current |
| 43547-411 | QUINAPRIL | quinapril | Solco Healthcare US, LLC | ANDA | Current |
| 43547-412 | QUINAPRIL | quinapril | Solco Healthcare US, LLC | ANDA | Current |
| 43547-412 | QUINAPRIL | quinapril | Solco Healthcare US, LLC | ANDA | Current |
| 43547-412 | QUINAPRIL | quinapril | Solco Healthcare US, LLC | ANDA | Current |
| 43547-413 | QUINAPRIL | quinapril | Solco Healthcare US, LLC | ANDA | Current |
| 43547-413 | QUINAPRIL | quinapril | Solco Healthcare US, LLC | ANDA | Current |
| 43547-413 | QUINAPRIL | quinapril | Solco Healthcare US, LLC | ANDA | Current |
| 50090-5400 | QUINAPRIL | quinapril | A-S Medication Solutions | ANDA | Current |
| 63629-8710 | QUINAPRIL | quinapril | Bryant Ranch Prepack | ANDA | Current |
| 70934-964 | QUINAPRIL | quinapril | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-484 | QUINAPRIL | quinapril | Proficient Rx LP | ANDA | Current |
| 71205-484 | QUINAPRIL | quinapril | Proficient Rx LP | ANDA | Current |
| 71335-1134 | QUINAPRIL | quinapril | Bryant Ranch Prepack | ANDA | Current |
| 71335-1134 | QUINAPRIL | quinapril | Bryant Ranch Prepack | ANDA | Current |
| 71335-1134 | QUINAPRIL | quinapril | Bryant Ranch Prepack | ANDA | Current |
| 71335-1262 | QUINAPRIL | quinapril | Bryant Ranch Prepack | ANDA | Current |
| 71335-1262 | QUINAPRIL | quinapril | Bryant Ranch Prepack | ANDA | Current |