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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080556
Company: FRESENIUS KABI USA

Products on ANDA 080556

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THIAMINE HYDROCHLORIDE	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080556

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/20/1972	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/14/2024	SUPPL-38	Labeling-Package Insert		Label is not available on this site.
08/15/2006	SUPPL-29	Labeling		Label is not available on this site.
07/14/2005	SUPPL-27	Labeling		Label is not available on this site.
07/30/1998	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
11/07/1997	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
11/04/1994	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
11/04/1994	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
08/30/1996	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
12/04/1990	SUPPL-18	Labeling		Label is not available on this site.
09/29/1983	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 080556

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	218471	ASPIRO
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	217800	GLAND
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	217181	ONESOURCE SPECIALTY
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

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