Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076979
Company: PH HEALTH

Products on ANDA 076979

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076979

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/08/2009	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/076979Orig1s000BioeqR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/26/2020	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
10/31/2015	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
07/12/2012	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
04/18/2012	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076979

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
CALCITONIN-SALMON	CALCITONIN SALMON	200 IU/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	076979	PH HEALTH