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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201831
Company: GLENMARK PHARMS LTD

Products on ANDA 201831

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.1MG	TABLET;ORAL	Prescription	AB	No	No
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.2MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201831

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/2015	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201831Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 201831

DESMOPRESSIN ACETATE

TABLET;ORAL; 0.1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DDAVP	DESMOPRESSIN ACETATE	0.1MG	TABLET;ORAL	Prescription	Yes	AB	019955	FERRING PHARMS INC
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.1MG	TABLET;ORAL	Prescription	No	AB	210371	ABHAI LLC
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.1MG	TABLET;ORAL	Prescription	No	AB	077414	APOTEX INC
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.1MG	TABLET;ORAL	Prescription	No	AB	213095	AUROBINDO PHARMA
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.1MG	TABLET;ORAL	Prescription	No	AB	201831	GLENMARK PHARMS LTD
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.1MG	TABLET;ORAL	Prescription	No	AB	207880	HERITAGE PHARMA
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.1MG	TABLET;ORAL	Prescription	No	AB	208357	NOVAST LABS

TABLET;ORAL; 0.2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DDAVP	DESMOPRESSIN ACETATE	0.2MG	TABLET;ORAL	Prescription	Yes	AB	019955	FERRING PHARMS INC
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.2MG	TABLET;ORAL	Prescription	No	AB	210371	ABHAI LLC
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.2MG	TABLET;ORAL	Prescription	No	AB	077414	APOTEX INC
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.2MG	TABLET;ORAL	Prescription	No	AB	213095	AUROBINDO PHARMA
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.2MG	TABLET;ORAL	Prescription	No	AB	201831	GLENMARK PHARMS LTD
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.2MG	TABLET;ORAL	Prescription	No	AB	207880	HERITAGE PHARMA
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.2MG	TABLET;ORAL	Prescription	No	AB	208357	NOVAST LABS

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