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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215336
Company: AMNEAL

Products on ANDA 215336

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 215336

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/06/2026	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
04/30/2026	SUPPL-12	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
09/23/2025	SUPPL-9	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 215336

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	074728	SANDOZ
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	213829	SOMERSET THERAPS LLC
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	078885	SUN PHARM
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	217957	UBI
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	215826	ZYDUS PHARMS

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