Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091345
Company: ZYDUS PHARMS

Products on ANDA 091345

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	DESMOPRESSIN ACETATE	0.01MG/SPRAY	SPRAY, METERED;NASAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091345

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/03/2017	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
10/25/2019	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091345

DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)

SPRAY, METERED;NASAL; 0.01MG/SPRAY
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.01MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	074830	BAUSCH
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	DESMOPRESSIN ACETATE	0.01MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	076703	APOTEX
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	DESMOPRESSIN ACETATE	0.01MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	091345	ZYDUS PHARMS