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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207389
Company: INVAGEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET;ORAL Discontinued None No No
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET;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
09/18/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/08/2023 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/08/2023 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

10/29/2020 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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