Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212416
Company: CUSTOPHARM INC

Products on ANDA 212416

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CALCITONIN-SALMON	CALCITONIN SALMON	200 IU/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212416

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/14/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212416Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 212416

CALCITONIN-SALMON

INJECTABLE;INJECTION; 200 IU/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CALCITONIN-SALMON	CALCITONIN SALMON	200 IU/ML	INJECTABLE;INJECTION	Prescription	No	AP	212416	CUSTOPHARM INC
CALCITONIN-SALMON	CALCITONIN SALMON	200 IU/ML	INJECTABLE;INJECTION	Prescription	No	AP	215715	DR REDDYS
CALCITONIN-SALMON	CALCITONIN SALMON	200 IU/ML	INJECTABLE;INJECTION	Prescription	No	AP	209358	ENDO OPERATIONS
MIACALCIN	CALCITONIN SALMON	200 IU/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017808	MYLAN IRELAND LTD