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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020655
Company: ABBVIE

Products on NDA 020655

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALORA	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued	None	No	No
ALORA	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued	None	No	No
ALORA	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued	None	No	No
ALORA	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020655

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
02/15/2024	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020655s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020655Orig1s023ltr.pdf
11/01/2017	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020655s020lbl.pdf
03/30/2020	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020655Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020655Orig1s019ltr.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.

Labels for NDA 020655

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020655s023lbl.pdf
03/30/2020	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020655Orig1s019lbl.pdf
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

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