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FDA ANDA · ANDA216055

ESTRADIOL

estradiol transdermal

Sponsor: AMNEAL

APPLICATION
ANDA216055
TYPE
ANDA
ORIGINAL APPROVAL
2024-07-12
LATEST ACTION
2024-07-12
ROUTE
TOPICAL, TRANSDERMAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

ESTRADIOLPrescription
ESTRADIOL 0.1% (1.25GM/PACKET) · GEL · TRANSDERMAL
ESTRADIOLPrescription
ESTRADIOL 0.1% (0.75GM/PACKET) · GEL · TRANSDERMAL
ESTRADIOLPrescription
ESTRADIOL 0.1% (0.25GM/PACKET) · GEL · TRANSDERMAL
ESTRADIOLPrescription
ESTRADIOL 0.1% (1GM/PACKET) · GEL · TRANSDERMAL
ESTRADIOLPrescription
ESTRADIOL 0.1% (0.5GM/PACKET) · GEL · TRANSDERMAL

Approval history

2024-07-12UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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