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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074921
Company: MAYNE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESTAZOLAM ESTAZOLAM 1MG TABLET;ORAL Prescription AB No No
ESTAZOLAM ESTAZOLAM 2MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/10/1997 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/17/2023 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

02/05/2021 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

02/06/2019 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/20/2008 SUPPL-12 Labeling

Label is not available on this site.

01/08/2009 SUPPL-11 Labeling

Label is not available on this site.

11/08/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

ESTAZOLAM

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTAZOLAM ESTAZOLAM 1MG TABLET;ORAL Prescription No AB 074921 MAYNE PHARMA
ESTAZOLAM ESTAZOLAM 1MG TABLET;ORAL Prescription No AB 074826 NOVITIUM PHARMA
ESTAZOLAM ESTAZOLAM 1MG TABLET;ORAL Prescription No AB 074818 WATSON LABS

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTAZOLAM ESTAZOLAM 2MG TABLET;ORAL Prescription No AB 074921 MAYNE PHARMA
ESTAZOLAM ESTAZOLAM 2MG TABLET;ORAL Prescription No AB 074826 NOVITIUM PHARMA
ESTAZOLAM ESTAZOLAM 2MG TABLET;ORAL Prescription No AB 074818 WATSON LABS
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