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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216432
Company: TP ANDA HOLDINGS

Products on ANDA 216432

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER;ORAL	Prescription	AB	No	No
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216432

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/03/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216432

SAPROPTERIN DIHYDROCHLORIDE

POWDER;ORAL; 100MG/PACKET
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KUVAN	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER;ORAL	Prescription	Yes	AB	205065	BIOMARIN PHARM
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER;ORAL	Prescription	No	AB	215420	ANNORA PHARMA
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER;ORAL	Prescription	No	AB	209452	DR REDDYS
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER;ORAL	Prescription	No	AB	219511	MICRO LABS
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER;ORAL	Prescription	No	AB	207207	PH HEALTH
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER;ORAL	Prescription	No	AB	216432	TP ANDA HOLDINGS
ZELVYSIA	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER;ORAL	Prescription	No	AB	218645	AUCTA

POWDER;ORAL; 500MG/PACKET
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KUVAN	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER;ORAL	Prescription	Yes	AB	205065	BIOMARIN PHARM
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER;ORAL	Prescription	No	AB	215420	ANNORA PHARMA
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER;ORAL	Prescription	No	AB	215798	DR REDDYS
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER;ORAL	Prescription	No	AB	219511	MICRO LABS
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER;ORAL	Prescription	No	AB	210027	PH HEALTH
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER;ORAL	Prescription	No	AB	216432	TP ANDA HOLDINGS
ZELVYSIA	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER;ORAL	Prescription	No	AB	218645	AUCTA

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