FDA.report

Application 021134

Type
NDA
Sponsor
PFIZER PHARMS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001NITROSTATNITROGLYCERINTABLET;SUBLINGUAL0.3MGYesNo
002NITROSTATNITROGLYCERINTABLET;SUBLINGUAL0.4MGYesNo
003NITROSTATNITROGLYCERINTABLET;SUBLINGUAL0.6MGYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0071-0417NitrostatnitroglycerinParke-Davis Div of Pfizer IncNDACurrent
0071-0418NitrostatnitroglycerinParke-Davis Div of Pfizer IncNDACurrent
0071-0419NitrostatnitroglycerinParke-Davis Div of Pfizer IncNDACurrent
0404-9929NITROSTATnitroglycerinHenry Schein, Inc.NDACurrent
21695-450NitrostatnitroglycerinRebel Distributors CorpNDACurrent
50090-0133NitrostatnitroglycerinA-S Medication SolutionsNDACurrent
50090-0133NitrostatnitroglycerinA-S Medication SolutionsNDACurrent
50090-0332NitrostatnitroglycerinA-S Medication SolutionsNDACurrent
50090-0332NitrostatnitroglycerinA-S Medication SolutionsNDACurrent
50090-0332NitrostatnitroglycerinA-S Medication SolutionsNDACurrent
50090-0332NitrostatnitroglycerinA-S Medication SolutionsNDACurrent
52584-418NITROSTATnitroglycerinGeneral Injectables & Vaccines, IncNDACurrent
52584-418NITROSTATnitroglycerinGeneral Injectables & Vaccines, IncNDACurrent
52584-418NITROSTATnitroglycerinGeneral Injectables & Vaccines, IncNDACurrent
52584-418NITROSTATnitroglycerinGeneral Injectables & Vaccines, IncNDACurrent
53217-066NitrostatnitroglycerinAidarex Pharmaceuticals LLCNDACurrent
55154-2433NitrostatnitroglycerinCardinal HealthNDACurrent
59762-0489NITROGLYCERINnitroglycerinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3304NITROGLYCERINnitroglycerinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4921NITROGLYCERINnitroglycerinGreenstone LLCNDA AUTHORIZED GENERICCurrent
63187-884NitrostatnitroglycerinProficient Rx LPNDACurrent
63187-884NitrostatnitroglycerinProficient Rx LPNDACurrent
68071-1720NitrostatnitroglycerinNuCare Pharmaceuticals,Inc.NDACurrent
68071-1720NitrostatnitroglycerinNuCare Pharmaceuticals,Inc.NDACurrent
68071-1720NitrostatnitroglycerinNuCare Pharmaceuticals,Inc.NDACurrent
70385-2014NitrostatnitroglycerinSina Health IncNDACurrent
70385-2018NITROGLYCERINnitroglycerinSina Health IncNDA AUTHORIZED GENERICCurrent
70518-0105NitrostatnitroglycerinREMEDYREPACK INC.NDACurrent
70518-0105NitrostatnitroglycerinREMEDYREPACK INC.NDACurrent
70518-0105NitrostatnitroglycerinREMEDYREPACK INC.NDACurrent

Documents

DocumentSubmission typeDate
51910SUPPL2018-01-26
51907SUPPL2018-01-26
48386SUPPL2017-05-17
47071SUPPL2017-01-31
45163SUPPL2016-08-29
45162SUPPL2016-08-29
36196SUPPL2014-03-10
26874SUPPL2014-03-10
26873SUPPL2011-07-25
14473SUPPL2011-07-25
36195SUPPL2010-07-22
4435SUPPL2010-07-21
36194ORIG2000-05-01
21468ORIG2000-05-01
4434ORIG2000-05-01