Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086069
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESTRACE ESTRADIOL 0.01% CREAM;VAGINAL Prescription AB Yes 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
01/31/1984 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
08/15/2018 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

06/21/2017 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

08/17/2005 SUPPL-18 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/86069s018lbl.pdf
03/27/2001 SUPPL-17 Manufacturing (CMC)-Facility Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/086069Orig1s017.pdf
08/11/2000 SUPPL-16 Labeling

Label is not available on this site.

08/11/2000 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/03/1998 SUPPL-12 Labeling

Label is not available on this site.

09/09/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/31/1996 SUPPL-10 Labeling

Label is not available on this site.

01/14/1994 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/23/1992 SUPPL-8 Labeling

Label is not available on this site.

06/07/1991 SUPPL-7 Labeling

Label is not available on this site.

03/11/1992 SUPPL-5 Labeling

Label is not available on this site.

10/16/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/17/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/17/2005 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/86069s018lbl.pdf

ESTRACE

CREAM;VAGINAL; 0.01%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRACE ESTRADIOL 0.01% CREAM;VAGINAL Prescription Yes AB 086069 ALLERGAN
ESTRADIOL ESTRADIOL 0.01% CREAM;VAGINAL Prescription No AB 209767 ALVOGEN
ESTRADIOL ESTRADIOL 0.01% CREAM;VAGINAL Prescription No AB 208788 MYLAN
ESTRADIOL ESTRADIOL 0.01% CREAM;VAGINAL Prescription No AB 210194 PADAGIS ISRAEL
ESTRADIOL ESTRADIOL 0.01% CREAM;VAGINAL Prescription No AB 212313 PRASCO LABS LLC
ESTRADIOL ESTRADIOL 0.01% CREAM;VAGINAL Prescription No AB 210488 TEVA PHARMS USA

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