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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214640
Company: XIROMED

Products on ANDA 214640

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL	Prescription	AB3	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214640

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/16/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214640Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 214640

LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

TABLET;ORAL; 0.02MG;0.1MG
TE Code = AB3

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BALCOLTRA	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL	Prescription	Yes	AB3	208612	AVION PHARMS
LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL	Prescription	No	AB3	214640	XIROMED
MINZOYA	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL	Prescription	No	AB3	217087	LUPIN LTD

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