Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076143
Company: APOTEX INC
Company: APOTEX INC
| 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 | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/17/2006 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/22/2024 | SUPPL-34 | Labeling, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/07/2024 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/10/2023 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/22/2022 | SUPPL-26 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/22/2022 | SUPPL-25 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 08/22/2022 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/22/2022 | SUPPL-21 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 08/22/2022 | SUPPL-19 | Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/22/2022 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/22/2022 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/20/2014 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/20/2014 | SUPPL-12 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/20/2014 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/16/2012 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/21/2011 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/08/2010 | SUPPL-8 | REMS-Proposal |
Label is not available on this site. |
||
| 01/22/2010 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/01/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/15/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/05/2006 | SUPPL-1 | Labeling |
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 |