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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076703
Company: APOTEX

Products on ANDA 076703

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076703

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/2005	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076703ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076703_ORIGINAL APPROVAL_PACKAGE.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/24/2019	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
10/24/2019	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
08/20/2009	SUPPL-17	Labeling		Label is not available on this site.
03/11/2008	SUPPL-14	Labeling		Label is not available on this site.
05/23/2007	SUPPL-10	Labeling		Label is not available on this site.
12/03/2006	SUPPL-9	Labeling		Label is not available on this site.
03/02/2006	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076703

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

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