Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076396
Company: APOTEX INC

Products on ANDA 076396

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CALCITONIN-SALMON	CALCITONIN SALMON	200 IU/SPRAY	SPRAY, METERED;NASAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076396

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/2008	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/076396Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/31/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
10/31/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
04/25/2012	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076396

CALCITONIN-SALMON

SPRAY, METERED;NASAL; 200 IU/SPRAY
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CALCITONIN-SALMON	CALCITONIN SALMON	200 IU/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	076396	APOTEX INC