Application 090540
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | TABLET;ORAL | EQ 75MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 33261-987 | Clopidogrel | Clopidogrel Bisulfate | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 50090-2082 | Clopidogrel | Clopidogrel Bisulfate | A-S Medication Solutions | ANDA | Current |
| 50090-2082 | Clopidogrel | Clopidogrel Bisulfate | A-S Medication Solutions | ANDA | Current |
| 50436-9986 | Clopidogrel | Clopidogrel Bisulfate | Unit Dose Services | ANDA | Current |
| 53002-1672 | Clopidogrel | Clopidogrel Bisulfate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1672 | Clopidogrel | Clopidogrel Bisulfate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53808-0616 | Clopidogrel | Clopidogrel Bisulfate | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55700-570 | Clopidogrel | Clopidogrel Bisulfate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 57237-189 | Clopidogrel | Clopidogrel Bisulfate | Citron Pharma LLC | ANDA | Current |
| 58118-0357 | Clopidogrel | Clopidogrel Bisulfate | Clinical Solutions Wholesale | ANDA | Current |
| 58118-0357 | Clopidogrel | Clopidogrel Bisulfate | Clinical Solutions Wholesale | ANDA | Current |
| 58118-0357 | Clopidogrel | Clopidogrel Bisulfate | Clinical Solutions Wholesale | ANDA | Current |
| 61919-007 | CLOPIDOGREL | CLOPIDOGREL | DIRECT RX | ANDA | Current |
| 61919-007 | CLOPIDOGREL | CLOPIDOGREL | DIRECT RX | ANDA | Current |
| 61919-007 | CLOPIDOGREL | CLOPIDOGREL | DIRECT RX | ANDA | Current |
| 61919-007 | CLOPIDOGREL | CLOPIDOGREL | DIRECT RX | ANDA | Current |
| 63629-6857 | Clopidogrel | Clopidogrel Bisulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-6857 | Clopidogrel | Clopidogrel Bisulfate | Bryant Ranch Prepack | ANDA | Current |
| 64205-357 | Clopidogrel | Clopidogrel Bisulfate | ReadyMeds | ANDA | Current |
| 64980-343 | Clopidogrel | Clopidogrel Bisulfate | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-343 | Clopidogrel | Clopidogrel Bisulfate | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-343 | Clopidogrel | Clopidogrel Bisulfate | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-343 | Clopidogrel | Clopidogrel Bisulfate | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-343 | Clopidogrel | Clopidogrel Bisulfate | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 65862-357 | Clopidogrel | Clopidogrel Bisulfate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-357 | Clopidogrel | Clopidogrel Bisulfate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-357 | Clopidogrel | Clopidogrel Bisulfate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-357 | Clopidogrel | Clopidogrel Bisulfate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-357 | Clopidogrel | Clopidogrel Bisulfate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-357 | Clopidogrel | Clopidogrel Bisulfate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-357 | Clopidogrel | Clopidogrel Bisulfate | Aurobindo Pharma Limited | ANDA | Current |
| 68071-1533 | Clopidogrel | Clopidogrel Bisulfate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3319 | Clopidogrel | Clopidogrel Bisulfate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4023 | Clopidogrel | Clopidogrel Bisulfate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68645-590 | Clopidogrel | Clopidogrel Bisulfate | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-590 | Clopidogrel | Clopidogrel Bisulfate | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-590 | Clopidogrel | Clopidogrel Bisulfate | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-590 | Clopidogrel | Clopidogrel Bisulfate | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-590 | Clopidogrel | Clopidogrel Bisulfate | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 70518-1898 | Clopidogrel | Clopidogrel Bisulfate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1898 | Clopidogrel | Clopidogrel Bisulfate | REMEDYREPACK INC. | ANDA | Current |
| 71205-073 | Clopidogrel | Clopidogrel Bisulfate | Proficient Rx LP | ANDA | Current |
| 71205-073 | Clopidogrel | Clopidogrel Bisulfate | Proficient Rx LP | ANDA | Current |
| 71205-073 | Clopidogrel | Clopidogrel Bisulfate | Proficient Rx LP | ANDA | Current |
| 71335-0080 | Clopidogrel | Clopidogrel Bisulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0080 | Clopidogrel | Clopidogrel Bisulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0080 | Clopidogrel | Clopidogrel Bisulfate | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9274 | ORIG | 2012-05-18 |