Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019466
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 5GM/100ML INJECTABLE;INJECTION Prescription AP Yes 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
07/15/1985 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
05/29/2019 SUPPL-62 Labeling-Package Insert

Label is not available on this site.

06/10/2016 SUPPL-57 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019465Orig1s054,019466Orig1s057,019479Orig1s049,019480Orig1s045,019759Orig1s046ltr.pdf
11/01/2002 SUPPL-40 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/06/2000 SUPPL-39 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/06/2000 SUPPL-38 Labeling

Label is not available on this site.

04/06/2000 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/31/1999 SUPPL-36 Labeling

Label is not available on this site.

12/01/1998 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

08/20/1997 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

06/11/1997 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

08/20/1997 SUPPL-32 Labeling

Label is not available on this site.

03/04/1996 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

08/18/1995 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/31/1995 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

01/24/1996 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

09/23/1994 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/05/1995 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/25/1994 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/30/1991 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/28/1992 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/10/1991 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/16/1993 SUPPL-16 Labeling

Label is not available on this site.

11/02/1990 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/09/1990 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/11/1990 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/22/1990 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/03/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/18/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/20/1989 SUPPL-9 Labeling

Label is not available on this site.

02/06/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/26/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/11/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/08/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/27/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/17/1986 SUPPL-1 Labeling

Label is not available on this site.

DEXTROSE 5% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 5GM/100ML INJECTABLE;INJECTION Prescription Yes AP 016730 B BRAUN
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 5GM/100ML INJECTABLE;INJECTION Prescription Yes AP 019626 B BRAUN
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 5GM/100ML INJECTABLE;INJECTION Prescription Yes AP 016673 BAXTER HLTHCARE
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 5GM/100ML INJECTABLE;INJECTION Prescription Yes AP 020179 BAXTER HLTHCARE
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 5GM/100ML INJECTABLE;INJECTION Prescription Yes AP 019466 HOSPIRA
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 5GM/100ML INJECTABLE;INJECTION Prescription Yes AP 019479 HOSPIRA

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