Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078789
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, 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
06/01/2011 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/078789Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/02/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

01/29/2014 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/29/2014 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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