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Last Updated: November 22, 2024

Suppliers and packages for tradename: LEUPROLIDE ACETATE

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LEUPROLIDE ACETATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal	LEUPROLIDE ACETATE	leuprolide acetate	SOLUTION;SUBCUTANEOUS	215336	ANDA	Amneal Pharmaceuticals LLC	70121-2537-6	1 KIT in 1 CARTON (70121-2537-6) * 1 VIAL, MULTI-DOSE in 1 CARTON (70121-1695-2) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (70121-2538-9)	2022-11-07
Eugia Pharma	LEUPROLIDE ACETATE	leuprolide acetate	SOLUTION;SUBCUTANEOUS	212963	ANDA	Eugia US LLC	55150-478-01	1 KIT in 1 CARTON (55150-478-01) * 1 VIAL, MULTI-DOSE in 1 CARTON (55150-338-01) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (60913-006-01)	2022-06-06
Meitheal	LEUPROLIDE ACETATE	leuprolide acetate	SOLUTION;SUBCUTANEOUS	075471	ANDA	Meitheal Pharmaceuticals Inc	71288-569-90	1 KIT in 1 CARTON (71288-569-90) * 1 VIAL, MULTI-DOSE in 1 CARTON (71288-565-03) / 2.8 mL in 1 VIAL, MULTI-DOSE * .5 mL in 1 PACKET (71288-350-91)	2024-05-15
Rk Pharma	LEUPROLIDE ACETATE	leuprolide acetate	SOLUTION;SUBCUTANEOUS	213829	ANDA	NorthStar RxLLC	72603-344-01	1 KIT in 1 CARTON (72603-344-01) * 1 VIAL, MULTI-DOSE in 1 CARTON (72603-201-01) / 2.8 mL in 1 VIAL, MULTI-DOSE * 28 PACKET in 1 CARTON / 1 mL in 1 PACKET	2024-03-01
Rk Pharma	LEUPROLIDE ACETATE	leuprolide acetate	SOLUTION;SUBCUTANEOUS	213829	ANDA	VGYAAN Pharmaceuticals LLC	72664-611-28	1 KIT in 1 CARTON (72664-611-28) * 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET	2020-10-25
Sandoz	LEUPROLIDE ACETATE	leuprolide acetate	SOLUTION;SUBCUTANEOUS	074728	ANDA	Sandoz Inc	0781-4003-32	1 KIT in 1 CARTON (0781-4003-32) * 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3006-42) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET	1998-08-04
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

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