Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213641
Company: AMPHASTAR PHARMS INC

Products on ANDA 213641

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TERIPARATIDE	TERIPARATIDE	0.56MG/2.24ML (0.25MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213641

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/12/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213641

TERIPARATIDE

SOLUTION;SUBCUTANEOUS; 0.56MG/2.24ML (0.25MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FORTEO	TERIPARATIDE	0.56MG/2.24ML (0.25MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	Yes	AP	021318	LILLY
TERIPARATIDE	TERIPARATIDE	0.56MG/2.24ML (0.25MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	Yes	AP	218771	ALMAJECT
TERIPARATIDE	TERIPARATIDE	0.56MG/2.24ML (0.25MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	213641	AMPHASTAR PHARMS INC
TERIPARATIDE	TERIPARATIDE	0.56MG/2.24ML (0.25MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	211097	APOTEX
TERIPARATIDE	TERIPARATIDE	0.56MG/2.24ML (0.25MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	208569	TEVA PHARMS USA