Drugs@FDA: FDA-Approved Drugs
Company: APNAR PHARMA LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | AB | No | No |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/07/2000 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75584ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75584_Bupropion.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/07/2024 | SUPPL-60 | Labeling, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/10/2023 | SUPPL-56 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/10/2023 | SUPPL-54 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/10/2023 | SUPPL-48 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/10/2023 | SUPPL-46 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/16/2015 | SUPPL-42 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/16/2015 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/24/2014 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/24/2014 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/28/2012 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/27/2012 | SUPPL-33 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 07/08/2010 | SUPPL-32 | REMS-Proposal |
Label is not available on this site. |
||
| 03/04/2010 | SUPPL-31 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/16/2009 | SUPPL-27 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/19/2007 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 12/19/2008 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 01/16/2008 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 02/08/2007 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 02/08/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 06/01/2005 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 02/04/2004 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/05/2002 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 01/18/2002 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/18/2002 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
BUPROPION HYDROCHLORIDE
TABLET;ORAL; 75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 203013 | ALEMBIC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 075584 | APNAR PHARMA LP |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 076143 | APOTEX INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 075491 | AUROBINDO PHARMA USA |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 208606 | CADILA PHARMS LTD |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 206975 | HERITAGE PHARMA |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 207403 | MICRO LABS |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 203013 | ALEMBIC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 075584 | APNAR PHARMA LP |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 076143 | APOTEX INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 075491 | AUROBINDO PHARMA USA |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 208606 | CADILA PHARMS LTD |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 206975 | HERITAGE PHARMA |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 207403 | MICRO LABS |