FDA.reportPublic FDA data

Application 020655

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALORAESTRADIOLFILM, EXTENDED RELEASE;TRANSDERMAL0.05MG/24HRNoNo
002ALORAESTRADIOLFILM, EXTENDED RELEASE;TRANSDERMAL0.075MG/24HRNoNo
003ALORAESTRADIOLFILM, EXTENDED RELEASE;TRANSDERMAL0.1MG/24HRNoNo
004ALORAESTRADIOLFILM, EXTENDED RELEASE;TRANSDERMAL0.025MG/24HRNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-5885AloraEstradiolAllergan, Inc.NDACurrent
0023-5885AloraEstradiolAllergan, Inc.NDACurrent
0023-5885AloraEstradiol Transdermal SystemAllergan, Inc.NDACurrent
0023-5885AloraEstradiolAllergan, Inc.NDACurrent
0023-5885AloraEstradiolAllergan, Inc.NDACurrent
0023-5886AloraEstradiolAllergan, Inc.NDACurrent
0023-5886AloraEstradiolAllergan, Inc.NDACurrent
0023-5886AloraEstradiolAllergan, Inc.NDACurrent
0023-5886AloraEstradiolAllergan, Inc.NDACurrent
0023-5886AloraEstradiol Transdermal SystemAllergan, Inc.NDACurrent
0023-5887AloraEstradiolAllergan, Inc.NDACurrent
0023-5887AloraEstradiolAllergan, Inc.NDACurrent
0023-5887AloraEstradiolAllergan, Inc.NDACurrent
0023-5887AloraEstradiolAllergan, Inc.NDACurrent
0023-5887AloraEstradiol Transdermal SystemAllergan, Inc.NDACurrent
0023-5888AloraEstradiol Transdermal SystemAllergan, Inc.NDACurrent
0023-5888AloraEstradiolAllergan, Inc.NDACurrent
0023-5888AloraEstradiolAllergan, Inc.NDACurrent
0023-5888AloraEstradiolAllergan, Inc.NDACurrent
0023-5888AloraEstradiolAllergan, Inc.NDACurrent
52544-471AloraEstradiolActavis Pharma, Inc.NDACurrent
52544-471AloraEstradiolActavis Pharma, Inc.NDACurrent
52544-471AloraEstradiolActavis Pharma, Inc.NDACurrent
52544-471AloraEstradiol Transdermal SystemActavis Pharma, Inc.NDACurrent
52544-472AloraEstradiolActavis Pharma, Inc.NDACurrent
52544-472AloraEstradiol Transdermal SystemActavis Pharma, Inc.NDACurrent
52544-472AloraEstradiolActavis Pharma, Inc.NDACurrent
52544-472AloraEstradiolActavis Pharma, Inc.NDACurrent
52544-473AloraEstradiolActavis Pharma, Inc.NDACurrent
52544-473AloraEstradiolActavis Pharma, Inc.NDACurrent
52544-473AloraEstradiolActavis Pharma, Inc.NDACurrent
52544-473AloraEstradiol Transdermal SystemActavis Pharma, Inc.NDACurrent
52544-884AloraEstradiolActavis Pharma, Inc.NDACurrent
52544-884AloraEstradiolActavis Pharma, Inc.NDACurrent
52544-884AloraEstradiolActavis Pharma, Inc.NDACurrent
52544-884AloraEstradiol Transdermal SystemActavis Pharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82164SUPPL 2025-05-08
82260SUPPL 2025-05-05
77530SUPPL 2024-02-16
77517SUPPL 2024-02-16
62369SUPPL2020-03-31
62367SUPPL2020-03-31
50261SUPPL2017-11-02
35078SUPPL2005-05-20
25447SUPPL2005-05-20
41523SUPPL2004-05-27
12923SUPPL2003-12-01
25446SUPPL2003-11-26
12924SUPPL2002-04-05
2998SUPPL2002-04-05