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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204044
Company: LABORATOIRE HRA

Products on ANDA 204044

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204044

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/03/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

LEVONORGESTREL

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 1.5MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ATHENTIA NEXT	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	206867	AUROBINDO PHARMA
FALLBACK SOLO	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	201446	LUPIN
HER STYLE	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	207976	NOVAST LABS
LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	219102	ANNORA PHARMA
LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	207044	GLENMARK PHARMS LTD
LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	204044	LABORATOIRE HRA
LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	202380	NAARI PTE
LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	207660	NAARI PTE
LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	202508	NOVEL LABS INC
LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	202334	PERRIGO R AND D
LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	202739	XIROMED
LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	205329	XIROMED
OPCICON ONE-STEP	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	202635	SUN PHARM
PLAN B ONE-STEP	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	Yes	021998	FDN CONSUMER

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