Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205794
Company: SCIEGEN PHARMS INC
Company: SCIEGEN PHARMS INC
| 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 |
|---|---|---|---|---|---|---|---|
| 03/01/2016 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205794Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/28/2023 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/22/2020 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/22/2020 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/03/2017 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/17/2017 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
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 |