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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077414
Company: APOTEX

Products on ANDA 077414

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 077414

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/07/2006	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
01/23/2015	SUPPL-8	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/077414Orig1S008LABL.pdf
09/03/2008	SUPPL-5	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077414

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
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	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
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	207880	HERITAGE PHARMA
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.2MG	TABLET;ORAL	Prescription	No	AB	208357	NOVAST LABS

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