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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040197
Company: BARR LABS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESTRADIOL ESTRADIOL 0.5MG TABLET;ORAL Prescription AB No No
ESTRADIOL ESTRADIOL 1MG TABLET;ORAL Prescription AB No No
ESTRADIOL ESTRADIOL 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
10/22/1997 ORIG-1 Approval Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/40197ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/15/2024 SUPPL-33 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.
08/24/2018 SUPPL-27 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.
05/01/2006 SUPPL-15 Labeling

Label is not available on this site.
06/22/2001 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.
01/02/2002 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.
09/24/1999 SUPPL-8 Labeling

Label is not available on this site.
12/21/1999 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.
05/20/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
05/07/1999 SUPPL-5 Labeling

Label is not available on this site.
05/07/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
12/01/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
04/07/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

ESTRADIOL

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRADIOL ESTRADIOL 0.5MG TABLET;ORAL Prescription No AB 040197 BARR LABS INC
ESTRADIOL ESTRADIOL 0.5MG TABLET;ORAL Prescription No AB 040275 EPIC PHARMA LLC
ESTRADIOL ESTRADIOL 0.5MG TABLET;ORAL Prescription No AB 217334 NOVITIUM PHARMA

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRADIOL ESTRADIOL 1MG TABLET;ORAL Prescription No AB 040197 BARR LABS INC
ESTRADIOL ESTRADIOL 1MG TABLET;ORAL Prescription No AB 040275 EPIC PHARMA LLC
ESTRADIOL ESTRADIOL 1MG TABLET;ORAL Prescription No AB 217334 NOVITIUM PHARMA

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRADIOL ESTRADIOL 2MG TABLET;ORAL Prescription No AB 040197 BARR LABS INC
ESTRADIOL ESTRADIOL 2MG TABLET;ORAL Prescription No AB 040275 EPIC PHARMA LLC
ESTRADIOL ESTRADIOL 2MG TABLET;ORAL Prescription No AB 217334 NOVITIUM PHARMA
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