Details for New Drug Application (NDA): 215420

NDA 215420 describes SAPROPTERIN DIHYDROCHLORIDE, which is a drug marketed by Annora Pharma, Dr Reddys, and Endo Operations, and is included in eight NDAs. It is available from four suppliers. Additional details are available on the SAPROPTERIN DIHYDROCHLORIDE profile page.

The generic ingredient in SAPROPTERIN DIHYDROCHLORIDE is sapropterin dihydrochloride. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.

Summary for 215420

Tradename:	SAPROPTERIN DIHYDROCHLORIDE
Applicant:	Annora Pharma
Ingredient:	sapropterin dihydrochloride
Patents:	0

Pharmacology for NDA: 215420

Mechanism of Action

Breast Cancer Resistance Protein Inhibitors P-Glycoprotein Inhibitors Phenylalanine Hydroxylase Activators

Suppliers and Packaging for NDA: 215420

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	POWDER;ORAL	215420	ANDA	Camber Pharmaceuticals, Inc.	31722-047	31722-047-30	30 PACKET in 1 CARTON (31722-047-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-047-01)
SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	POWDER;ORAL	215420	ANDA	Camber Pharmaceuticals, Inc.	31722-047	31722-047-31	1 PACKET in 1 CARTON (31722-047-31) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-047-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;ORAL			Strength	100MG/PACKET
Approval Date:	Aug 18, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;ORAL			Strength	500MG/PACKET
Approval Date:	Aug 18, 2022	TE:	AB	RLD:	No

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