Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS LABS FL INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB3 | No | No |
BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
06/13/2007 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2007/077715Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/23/2024 | SUPPL-50 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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08/02/2023 | SUPPL-45 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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08/02/2023 | SUPPL-44 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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08/02/2023 | SUPPL-42 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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10/16/2020 | SUPPL-38 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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10/16/2020 | SUPPL-34 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/20/2014 | SUPPL-31 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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04/23/2012 | SUPPL-23 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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08/30/2010 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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04/27/2010 | SUPPL-20 | REMS-Proposal |
Label is not available on this site. |
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02/04/2010 | SUPPL-18 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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11/09/2009 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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11/26/2008 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/26/2008 | SUPPL-6 | Labeling |
Label is not available on this site. |
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07/09/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
BUPROPION HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL; 150MG
TE Code = AB3
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 | AB3 | 210497 | ACCORD HLTHCARE |
BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 077715 | ACTAVIS LABS FL INC |
BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 207224 | ANBISON LAB |
BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 215568 | GRANULES |
BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 211020 | GRAVITI PHARMS |
BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 090693 | LUPIN LTD |
BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 207479 | SCIEGEN PHARMS INC |
BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 208652 | SINOTHERAPEUTICS INC |
BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 200216 | SUN PHARM |
BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 210081 | TWI PHARMS |
BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 077285 | WATSON LABS INC |
BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 202189 | WOCKHARDT LTD |
BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 210015 | YICHANG HUMANWELL |
BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 211200 | ZHEJIANG JUTAI PHARM |
BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 201567 | ZYDUS PHARMS |
WELLBUTRIN XL | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB3 | 021515 | BAUSCH |