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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220407
Company: ZYDUS PHARMS

Products on ANDA 220407

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTRADIOL AND LEVONORGESTREL	ESTRADIOL; LEVONORGESTREL	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220407

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/19/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 220407

ESTRADIOL AND LEVONORGESTREL

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.045MG/24HR;0.015MG/24HR
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLIMARA PRO	ESTRADIOL; LEVONORGESTREL	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	Yes	AB	021258	BAYER HLTHCARE
ESTRADIOL AND LEVONORGESTREL	ESTRADIOL; LEVONORGESTREL	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	No	AB	220407	ZYDUS PHARMS

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