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Last Updated: November 22, 2024

Suppliers and packages for tradename: SAPROPTERIN DIHYDROCHLORIDE

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SAPROPTERIN DIHYDROCHLORIDE

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
Annora Pharma	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	POWDER;ORAL	215420	ANDA	Camber Pharmaceuticals, Inc.	31722-047-30	30 PACKET in 1 CARTON (31722-047-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-047-01)	2022-08-18
Annora Pharma	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	POWDER;ORAL	215420	ANDA	Camber Pharmaceuticals, Inc.	31722-047-31	1 PACKET in 1 CARTON (31722-047-31) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-047-01)	2022-08-18
Annora Pharma	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	POWDER;ORAL	215420	ANDA	Camber Pharmaceuticals, Inc.	31722-048-30	30 PACKET in 1 CARTON (31722-048-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-048-01)	2022-08-18
Annora Pharma	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	POWDER;ORAL	215420	ANDA	Camber Pharmaceuticals, Inc.	31722-048-31	1 PACKET in 1 CARTON (31722-048-31) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-048-01)	2022-08-18
Annora Pharma	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	POWDER;ORAL	215420	ANDA	NorthStar RxLLC	72603-193-30	30 PACKET in 1 CARTON (72603-193-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (72603-193-01)	2023-12-01
Annora Pharma	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	POWDER;ORAL	215420	ANDA	NorthStar RxLLC	72603-194-30	30 PACKET in 1 CARTON (72603-194-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (72603-194-01)	2023-12-01
Dr Reddys	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	POWDER;ORAL	209452	ANDA	Dr. Reddys Laboratories Inc	43598-097-30	30 PACKET in 1 CARTON (43598-097-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (43598-097-11)	2022-09-16
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

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