Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075932
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB1 | No | No |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB1 | No | No |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB1 | 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 |
|---|---|---|---|---|---|---|---|
| 11/25/2003 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75932TAF.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075932_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/02/2022 | SUPPL-49 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/11/2021 | SUPPL-47 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/11/2021 | SUPPL-46 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/11/2021 | SUPPL-43 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/15/2016 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/15/2016 | SUPPL-38 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 07/15/2016 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/20/2014 | SUPPL-34 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/20/2014 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/18/2012 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/25/2010 | SUPPL-30 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/08/2010 | SUPPL-29 | Labeling-Container/Carton Labels, Labeling-Medication Guide, REMS-Proposal |
Label is not available on this site. |
||
| 04/05/2010 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/05/2009 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2008 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 02/05/2008 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 06/04/2007 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/06/2006 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 08/01/2005 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 11/18/2004 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 06/22/2005 | SUPPL-13 |
Label is not available on this site. |
|||
| 06/22/2005 | SUPPL-12 |
Label is not available on this site. |
|||
| 11/18/2004 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/28/2004 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 06/22/2005 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/22/2005 | SUPPL-4 |
Label is not available on this site. |
|||
| 11/18/2004 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/22/2004 | SUPPL-2 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75932s001s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075932_S002_AP.pdf |
| 03/22/2004 | SUPPL-1 |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75932s001s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075932_S001_AP.pdf |
BUPROPION HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 079095 | ACTAVIS LABS FL INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 216800 | ANNORA PHARMA |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 075932 | EPIC PHARMA LLC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 075913 | IMPAX LABS |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 202304 | PRINSTON INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 205794 | SCIEGEN PHARMS INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 211347 | YICHANG HUMANWELL |
| WELLBUTRIN SR | BUPROPION HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB1 | 020358 | GLAXOSMITHKLINE |
TABLET, EXTENDED RELEASE;ORAL; 150MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 079095 | ACTAVIS LABS FL INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 216800 | ANNORA PHARMA |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 075932 | EPIC PHARMA LLC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 075913 | IMPAX LABS |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 202304 | PRINSTON INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 205794 | SCIEGEN PHARMS INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 078866 | SUN PHARM |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 211347 | YICHANG HUMANWELL |
| WELLBUTRIN SR | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB1 | 020358 | GLAXOSMITHKLINE |
TABLET, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 079095 | ACTAVIS LABS FL INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 216800 | ANNORA PHARMA |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 075932 | EPIC PHARMA LLC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 202304 | PRINSTON INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 205794 | SCIEGEN PHARMS INC |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 211347 | YICHANG HUMANWELL |
| WELLBUTRIN SR | BUPROPION HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB1 | 020358 | GLAXOSMITHKLINE |