Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 080618
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE HYDROCHLORIDE 100MG/ML INJECTABLE;INJECTION Prescription None 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
08/14/1972 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
09/22/2014 SUPPL-31 Labeling

Label is not available on this site.

07/14/2005 SUPPL-29 Labeling

Label is not available on this site.

11/25/1997 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/18/1995 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/22/1996 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/22/1996 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/22/1996 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/20/1991 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/07/1983 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/10/1983 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/26/1983 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English