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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215715
Company: DR REDDYS

Products on ANDA 215715

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 215715

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/11/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215715

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	PAR STERILE PRODUCTS
MIACALCIN	CALCITONIN SALMON	200 IU/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017808	MYLAN IRELAND LTD

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