Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215798
Company: DR REDDYS

Products on ANDA 215798

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215798

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/13/2022	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
03/15/2024	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
09/26/2022	SUPPL-1	Labeling-Proprietary Name Change		Label is not available on this site.

Therapeutic Equivalents for ANDA 215798

SAPROPTERIN DIHYDROCHLORIDE

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	210027	PAR PHARM INC