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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074826
Company: NOVITIUM 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 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
07/03/1997 ORIG-1 Approval Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/74826ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/17/2023 SUPPL-24 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
08/02/2021 SUPPL-20 Labeling-Container/Carton Labels, 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-18 Labeling-Package Insert

Label is not available on this site.
12/16/2016 SUPPL-17 Labeling-Package Insert

Label is not available on this site.
09/09/2008 SUPPL-15 Labeling

Label is not available on this site.
09/16/2007 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.
07/29/2002 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.
01/28/2000 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.
04/21/2000 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.
04/21/2000 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.
04/21/2000 SUPPL-5 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.
04/21/2000 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
11/23/1999 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.
12/09/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
02/25/1998 SUPPL-1 Manufacturing (CMC)

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 DR REDDYS LABS SA
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 DR REDDYS LABS SA
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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