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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091280
Company: SUN PHARM INDS LTD

Products on ANDA 091280

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 091280

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/25/2013	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/27/2023	SUPPL-20	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091280

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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