Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019970
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NITROGLYCERIN IN DEXTROSE 5% NITROGLYCERIN 10MG/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
NITROGLYCERIN IN DEXTROSE 5% NITROGLYCERIN 20MG/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
NITROGLYCERIN IN DEXTROSE 5% NITROGLYCERIN 40MG/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
12/29/1989 ORIG-1 Approval Type 3 - New Dosage Form 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
08/22/2016 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019970s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019970Orig1s018ltr.pdf
06/17/2015 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/02/2014 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019970s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019970Orig1s015ltr.pdf
12/31/2013 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

02/01/2013 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/06/2000 SUPPL-11 Labeling

Label is not available on this site.

04/21/1999 SUPPL-10 Labeling

Label is not available on this site.

12/09/1998 SUPPL-9 Labeling

Label is not available on this site.

11/03/1995 SUPPL-8 Labeling

Label is not available on this site.

03/24/1995 SUPPL-7 Labeling

Label is not available on this site.

09/29/1994 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1994 SUPPL-5 Labeling

Label is not available on this site.

08/02/1991 SUPPL-4 Labeling

Label is not available on this site.

06/01/1990 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/16/1990 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/1990 SUPPL-1 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
08/22/2016 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019970s018lbl.pdf
10/02/2014 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019970s015lbl.pdf

NITROGLYCERIN IN DEXTROSE 5%

INJECTABLE;INJECTION; 10MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NITROGLYCERIN IN DEXTROSE 5% NITROGLYCERIN 10MG/100ML INJECTABLE;INJECTION Prescription Yes AP 019970 BAXTER HLTHCARE

INJECTABLE;INJECTION; 20MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NITROGLYCERIN IN DEXTROSE 5% NITROGLYCERIN 20MG/100ML INJECTABLE;INJECTION Prescription Yes AP 019970 BAXTER HLTHCARE

INJECTABLE;INJECTION; 40MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NITROGLYCERIN IN DEXTROSE 5% NITROGLYCERIN 40MG/100ML INJECTABLE;INJECTION Prescription Yes AP 019970 BAXTER HLTHCARE

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