Drugs@FDA: FDA-Approved Drugs
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. |
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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 |