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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213829
Company: RK PHARMA

Products on ANDA 213829

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION;SUBCUTANEOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213829

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/13/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213829

LEUPROLIDE ACETATE

SOLUTION;SUBCUTANEOUS; 14MG/2.8ML (1MG/0.2ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	215336	AMNEAL
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	212963	EUGIA PHARMA
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	075471	MEITHEAL
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	213829	RK PHARMA
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	074728	SANDOZ
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	078885	SUN PHARM

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