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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219324
Company: TEVA PHARMS INC

Products on ANDA 219324

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LO JUNEL FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.01MG,0.01MG;1MG,N/A	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219324

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/22/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219324

LO JUNEL FE

TABLET;ORAL; 0.01MG,0.01MG;1MG,N/A
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LO JUNEL FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.01MG,0.01MG;1MG,N/A	TABLET;ORAL	Prescription	No	AB	219324	TEVA PHARMS INC
LO LOESTRIN FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.01MG,0.01MG;1MG,N/A	TABLET;ORAL	Prescription	Yes	AB	022501	APIL

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