Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016730
Company: B BRAUN
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
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 50MG/ML 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
12/21/1973 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
09/29/2014 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

10/19/2006 SUPPL-50 Labeling

Label is not available on this site.

08/06/2004 SUPPL-48 Labeling

Label is not available on this site.

06/23/1997 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

08/08/1995 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

12/31/1991 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

09/11/1990 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

03/09/1989 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

01/30/1986 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

06/24/1985 SUPPL-36 Labeling

Label is not available on this site.

09/16/1985 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

10/16/1984 SUPPL-34 Labeling

Label is not available on this site.

10/17/1984 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

04/03/1985 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

04/09/1984 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

09/30/1983 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

05/17/1985 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

02/18/1986 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/21/1985 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

11/05/1982 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

06/28/1982 SUPPL-23 Labeling

Label is not available on this site.

06/28/1982 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/26/1981 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/24/1983 SUPPL-20 Labeling

Label is not available on this site.

09/30/1981 SUPPL-19 Labeling

Label is not available on this site.

09/30/1981 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/24/1980 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/06/1980 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/16/1980 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/12/1980 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/09/1979 SUPPL-13 Labeling

Label is not available on this site.

10/16/1979 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/08/1979 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/14/1979 SUPPL-10 Labeling

Label is not available on this site.

10/12/1978 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/12/1979 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/28/1978 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/02/1978 SUPPL-6 Labeling

Label is not available on this site.

11/02/1978 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/21/1977 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/19/1977 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/25/1977 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/06/1976 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

INJECTABLE;INJECTION; 50MG/ML
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 50MG/ML INJECTABLE;INJECTION Prescription Yes AP 016730 B BRAUN
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 50MG/ML INJECTABLE;INJECTION Prescription Yes AP 016673 BAXTER HLTHCARE
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 50MG/ML INJECTABLE;INJECTION Prescription Yes AP 020179 BAXTER HLTHCARE
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 50MG/ML INJECTABLE;INJECTION Prescription No AP 207449 FRESENIUS KABI USA
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 50MG/ML INJECTABLE;INJECTION Prescription Yes AP 016367 ICU MEDICAL INC

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