Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 083914
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5% LIDOCAINE HYDROCHLORIDE 5% INJECTABLE;SPINAL 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
01/23/1974 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
11/02/2018 SUPPL-40 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

04/08/2010 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

02/24/1997 SUPPL-24 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/03/1996 SUPPL-23 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/24/1996 SUPPL-22 Labeling

Label is not available on this site.

11/02/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/07/1989 SUPPL-19 Labeling

Label is not available on this site.

06/13/1989 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/20/1988 SUPPL-17 Labeling

Label is not available on this site.

08/09/1985 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/18/1984 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/23/1982 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/22/1982 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/22/1982 SUPPL-11 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