Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209452
Company: DR REDDYS

Products on ANDA 209452

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209452

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209452Orig1s000TAltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/15/2024	SUPPL-6	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/17/2022	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Proprietary Name Change, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209452

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	207207	PAR PHARM INC