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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211293
Company: AMNEAL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESTRADIOL ESTRADIOL 0.025MG/24HR SYSTEM;TRANSDERMAL Prescription AB1 No No
ESTRADIOL ESTRADIOL 0.0375MG/24HR SYSTEM;TRANSDERMAL Prescription AB1 No No
ESTRADIOL ESTRADIOL 0.05MG/24HR SYSTEM;TRANSDERMAL Prescription AB1 No No
ESTRADIOL ESTRADIOL 0.075MG/24HR SYSTEM;TRANSDERMAL Prescription AB1 No No
ESTRADIOL ESTRADIOL 0.1MG/24HR SYSTEM;TRANSDERMAL Prescription AB1 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
02/05/2019 ORIG-1 Approval 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
08/26/2024 SUPPL-11 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.
11/16/2023 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

ESTRADIOL

SYSTEM;TRANSDERMAL; 0.025MG/24HR
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRADIOL ESTRADIOL 0.025MG/24HR SYSTEM;TRANSDERMAL Prescription No AB1 211293 AMNEAL
ESTRADIOL ESTRADIOL 0.025MG/24HR SYSTEM;TRANSDERMAL Prescription No AB1 201675 MYLAN TECHNOLOGIES
ESTRADIOL ESTRADIOL 0.025MG/24HR SYSTEM;TRANSDERMAL Prescription No AB1 206241 ZYDUS PHARMS
VIVELLE-DOT ESTRADIOL 0.025MG/24HR SYSTEM;TRANSDERMAL Prescription Yes AB1 020538 SANDOZ

SYSTEM;TRANSDERMAL; 0.0375MG/24HR
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRADIOL ESTRADIOL 0.0375MG/24HR SYSTEM;TRANSDERMAL Prescription No AB1 211293 AMNEAL
ESTRADIOL ESTRADIOL 0.0375MG/24HR SYSTEM;TRANSDERMAL Prescription No AB1 201675 MYLAN TECHNOLOGIES
ESTRADIOL ESTRADIOL 0.0375MG/24HR SYSTEM;TRANSDERMAL Prescription No AB1 206241 ZYDUS PHARMS
VIVELLE-DOT ESTRADIOL 0.0375MG/24HR SYSTEM;TRANSDERMAL Prescription Yes AB1 020538 SANDOZ

SYSTEM;TRANSDERMAL; 0.05MG/24HR
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRADIOL ESTRADIOL 0.05MG/24HR SYSTEM;TRANSDERMAL Prescription No AB1 211293 AMNEAL
ESTRADIOL ESTRADIOL 0.05MG/24HR SYSTEM;TRANSDERMAL Prescription No AB1 201675 MYLAN TECHNOLOGIES
ESTRADIOL ESTRADIOL 0.05MG/24HR SYSTEM;TRANSDERMAL Prescription No AB1 206241 ZYDUS PHARMS
VIVELLE-DOT ESTRADIOL 0.05MG/24HR SYSTEM;TRANSDERMAL Prescription Yes AB1 020538 SANDOZ

SYSTEM;TRANSDERMAL; 0.075MG/24HR
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRADIOL ESTRADIOL 0.075MG/24HR SYSTEM;TRANSDERMAL Prescription No AB1 211293 AMNEAL
ESTRADIOL ESTRADIOL 0.075MG/24HR SYSTEM;TRANSDERMAL Prescription No AB1 201675 MYLAN TECHNOLOGIES
ESTRADIOL ESTRADIOL 0.075MG/24HR SYSTEM;TRANSDERMAL Prescription No AB1 206241 ZYDUS PHARMS
VIVELLE-DOT ESTRADIOL 0.075MG/24HR SYSTEM;TRANSDERMAL Prescription Yes AB1 020538 SANDOZ

SYSTEM;TRANSDERMAL; 0.1MG/24HR
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRADIOL ESTRADIOL 0.1MG/24HR SYSTEM;TRANSDERMAL Prescription No AB1 211293 AMNEAL
ESTRADIOL ESTRADIOL 0.1MG/24HR SYSTEM;TRANSDERMAL Prescription No AB1 201675 MYLAN TECHNOLOGIES
ESTRADIOL ESTRADIOL 0.1MG/24HR SYSTEM;TRANSDERMAL Prescription No AB1 206241 ZYDUS PHARMS
VIVELLE-DOT ESTRADIOL 0.1MG/24HR SYSTEM;TRANSDERMAL Prescription Yes AB1 020538 SANDOZ
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