Drugs@FDA: FDA Approved Drug Products

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

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 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

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