Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206106
Company: SAGENT PHARMS INC

Products on ANDA 206106

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THIAMINE HYDROCHLORIDE	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206106

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/01/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 206106

THIAMINE HYDROCHLORIDE

INJECTABLE;INJECTION; 100MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
THIAMINE HYDROCHLORIDE	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	215692	CAPLIN
THIAMINE HYDROCHLORIDE	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	080571	DR REDDYS
THIAMINE HYDROCHLORIDE	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	208703	EUGIA PHARMA
THIAMINE HYDROCHLORIDE	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	080556	FRESENIUS KABI USA
THIAMINE HYDROCHLORIDE	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	091623	MYLAN INSTITUTIONAL
THIAMINE HYDROCHLORIDE	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	206106	SAGENT PHARMS INC
THIAMINE HYDROCHLORIDE	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	080575	WEST-WARD PHARMS INT