Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203683
Company: WATSON LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Discontinued None No No
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Discontinued None No No
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Discontinued None No No
NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE 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
11/27/2015 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203683Orig1s000Ltr.pdf

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