Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018388
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 200MG/100ML INJECTABLE;INJECTION Discontinued None No No
LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 400MG/100ML INJECTABLE;INJECTION Discontinued None No No
LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 800MG/100ML INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/19/1980 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/09/2014 SUPPL-86 Manufacturing (CMC)

Label is not available on this site.

04/07/2014 SUPPL-85 Manufacturing (CMC)

Label is not available on this site.

01/15/2014 SUPPL-84 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018388s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018388Orig1s084ltr.pdf
08/26/1999 SUPPL-67 Labeling

Label is not available on this site.

11/05/1998 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

06/12/1997 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

08/26/1999 SUPPL-64 Labeling

Label is not available on this site.

03/18/1997 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

07/09/1996 SUPPL-62 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/02/1996 SUPPL-61 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/03/1995 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

07/17/1996 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/1996 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

08/17/1995 SUPPL-56 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/03/1993 SUPPL-55 Labeling

Label is not available on this site.

08/30/1991 SUPPL-54 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/28/1992 SUPPL-53 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/10/1991 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1990 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

02/22/1990 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

05/01/1992 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/1986 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1986 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1985 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

05/10/1985 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

12/15/1986 SUPPL-41 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/31/1986 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1985 SUPPL-39 Labeling

Label is not available on this site.

11/01/1985 SUPPL-38 Labeling

Label is not available on this site.

05/03/1985 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1985 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1985 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/22/1984 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

09/26/1985 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/29/1985 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/28/1984 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1989 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1984 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/1984 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/1984 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

09/06/1983 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/1983 SUPPL-21 Labeling

Label is not available on this site.

12/08/1983 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

02/17/1984 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

10/10/1984 SUPPL-18 Labeling

Label is not available on this site.

10/10/1984 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/26/1982 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1984 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1983 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/08/1982 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

11/05/1982 SUPPL-12 Labeling

Label is not available on this site.

11/05/1982 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1982 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

01/08/1982 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/09/1982 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1981 SUPPL-6 Labeling

Label is not available on this site.

04/21/1981 SUPPL-5 Labeling

Label is not available on this site.

04/21/1981 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/22/1981 SUPPL-3 Labeling

Label is not available on this site.

05/16/1981 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/15/2014 SUPPL-84 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018388s084lbl.pdf

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