Application 077715
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 150MG | No | No |
| 002 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 300MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0591-3331 | Bupropion Hydrochloride | Bupropion Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3331 | Bupropion Hydrochloride | Bupropion Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3331 | Bupropion Hydrochloride | Bupropion Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3331 | Bupropion Hydrochloride | Bupropion Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3331 | Bupropion Hydrochloride | Bupropion Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3331 | Bupropion Hydrochloride | Bupropion Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 21695-279 | Bupropion Hydrochloride | Bupropion Hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 21695-578 | Bupropion Hydrochloride | Bupropion Hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 35356-627 | Bupropion Hydrochloride | Bupropion Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 50090-3139 | Bupropion Hydrochloride | Bupropion Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4049 | Bupropion Hydrochloride | Bupropion Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 53002-1495 | Bupropion Hydrochloride | Bupropion Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1495 | Bupropion Hydrochloride | Bupropion Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53217-279 | Bupropion HydrochlorideXL | Bupropion Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 54868-5927 | Bupropion | bupropion hydrochloride | Physicians Total Care, Inc. | ANDA | Current |
| 60429-933 | Bupropion Hydrochloride | Bupropion Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-933 | Bupropion Hydrochloride | Bupropion Hydrochloride | Golden State Medical Supply | ANDA | Current |
| 60429-933 | Bupropion Hydrochloride | Bupropion Hydrochloride | Golden State Medical Supply | ANDA | Current |
| 63187-766 | Bupropion Hydrochloride | Bupropion Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-766 | Bupropion Hydrochloride | Bupropion Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-766 | Bupropion Hydrochloride | Bupropion Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63629-3316 | Bupropion Hydrochloride | Bupropion Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 68258-7067 | Bupropion Hydrochloride | Bupropion Hydrochloride | Dispensing Solutions, Inc. | ANDA | Current |
| 68258-7126 | Bupropion Hydrochloride | Bupropion Hydrochloride | Dispensing Solutions, Inc. | ANDA | Current |
| 70934-172 | Bupropion Hydrochloride | Bupropion Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-172 | Bupropion Hydrochloride | Bupropion Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-172 | Bupropion Hydrochloride | Bupropion Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 22610 | ORIG | 2011-12-16 |
| 44362 | ORIG | 2007-06-18 |