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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204695
Company: SAGENT PHARMS INC

Products on ANDA 204695

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204695

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/22/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204695Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/25/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204695

DESMOPRESSIN ACETATE

INJECTABLE;INJECTION; 0.004MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DDAVP	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018938	FERRING PHARMS INC
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	215961	DR REDDYS
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	216904	GLAND
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	216922	GLAND PHARMA LTD
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	074888	MEITHEAL
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	204695	SAGENT PHARMS INC
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	204751	SAGENT PHARMS INC
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	091280	SUN PHARM INDS LTD
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210218	UBI
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.004MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210223	UBI

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