Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 215864
Company: ZYDUS PHARMS

Products on ANDA 215864

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 215864

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/04/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215864

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	216294	AMNEAL
CALCITONIN-SALMON	CALCITONIN SALMON	200 IU/ML	INJECTABLE;INJECTION	Prescription	No	AP	213766	CIPLA
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	212675	FRESENIUS KABI USA
CALCITONIN-SALMON	CALCITONIN SALMON	200 IU/ML	INJECTABLE;INJECTION	Prescription	No	AP	209358	PH HEALTH
CALCITONIN-SALMON	CALCITONIN SALMON	200 IU/ML	INJECTABLE;INJECTION	Prescription	No	AP	219196	SAGENT
CALCITONIN-SALMON	CALCITONIN SALMON	200 IU/ML	INJECTABLE;INJECTION	Prescription	No	AP	215864	ZYDUS PHARMS
MIACALCIN	CALCITONIN SALMON	200 IU/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017808	MYLAN IRELAND LTD