← FDA DRUG APPROVALS

FDA ANDA · ANDA211783

ESTRADIOL

estradiol gel 0.1%

Sponsor: XIROMED

APPLICATION
ANDA211783
TYPE
ANDA
ORIGINAL APPROVAL
2022-08-10
LATEST ACTION
2022-08-10
ROUTE
TOPICAL, TRANSDERMAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

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

Approval history

2022-08-10UNKNOWN · Original · standard — Letter ↗AP
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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