Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020655
Company: ALLERGAN SALES LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALORA ESTRADIOL 0.05MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription BX No No
ALORA ESTRADIOL 0.075MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription BX No No
ALORA ESTRADIOL 0.1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription BX No No
ALORA ESTRADIOL 0.025MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription BX 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
12/20/1996 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/01/2017 SUPPL-20 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020655s020lbl.pdf
08/30/2013 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/19/2005 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020655s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020655s011ltr.pdf
04/05/2002 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20655s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20655s8ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-665s008_Alora.cfm
10/02/2001 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/18/2003 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20655slr006_alora_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20655slr006ltr.pdf
04/14/2000 SUPPL-5 Labeling

Label is not available on this site.

06/04/1999 SUPPL-4 Labeling

Label is not available on this site.

11/24/1998 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/22/1998 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

10/06/1997 SUPPL-1 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
11/01/2017 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020655s020lbl.pdf
05/19/2005 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020655s011lbl.pdf
11/18/2003 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20655slr006_alora_lbl.pdf
04/05/2002 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20655s8lbl.pdf

ALORA

There are no Therapeutic Equivalents.

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