Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091328
Company: LUPIN LTD

Products on ANDA 091328

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVONORGESTREL	LEVONORGESTREL	0.75MG	TABLET;ORAL	Discontinued	None	No	No
LEVONORGESTREL	LEVONORGESTREL	0.75MG	TABLET; ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091328

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/23/2013	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2013/091328Orig1s000.pdf

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; 0.75MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
LEVONORGESTREL	LEVONORGESTREL	0.75MG	TABLET; ORAL	Over-the-counter	No	091328	LUPIN LTD