FDA.reportPublic FDA data

Application 017442

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MINIPRESSPRAZOSIN HYDROCHLORIDECAPSULE;ORALEQ 5MG BASEYesNo
002MINIPRESSPRAZOSIN HYDROCHLORIDECAPSULE;ORALEQ 1MG BASEYesNo
003MINIPRESSPRAZOSIN HYDROCHLORIDECAPSULE;ORALEQ 2MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-4310Minipressprazosin hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4310Minipressprazosin hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4310Minipressprazosin hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4370Minipressprazosin hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4370Minipressprazosin hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4370Minipressprazosin hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4380Minipressprazosin hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4380Minipressprazosin hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4380Minipressprazosin hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
50090-3072Prazosinprazosin hydrochlorideA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
59762-5310Prazosin Hydrochlorideprazosin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5310Prazosin Hydrochlorideprazosin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5310Prazosinprazosin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5310Prazosinprazosin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5320Prazosinprazosin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5320Prazosin Hydrochlorideprazosin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5320Prazosinprazosin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5320Prazosin Hydrochlorideprazosin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5350Prazosin Hydrochlorideprazosin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5350Prazosinprazosin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5350Prazosinprazosin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5350Prazosin Hydrochlorideprazosin hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
66993-431Prazosin Hydrochlorideprazosin hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-431Prazosin Hydrochlorideprazosin hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-432Prazosin Hydrochlorideprazosin hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-433Prazosin Hydrochlorideprazosin hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
70518-1884Prazosinprazosin hydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1884Prazosinprazosin hydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1884Prazosinprazosin hydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1884Prazosinprazosin hydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1895Prazosinprazosin hydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1895Prazosinprazosin hydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1895Prazosinprazosin hydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1895Prazosinprazosin hydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2065Prazosinprazosin hydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2065Prazosinprazosin hydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2065Prazosinprazosin hydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2065Prazosinprazosin hydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2065Prazosinprazosin hydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-3271Prazosin Hydrochlorideprazosin hydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
13140SUPPL2015-03-02
10991SUPPL2015-03-02
13139SUPPL2013-11-07
10990SUPPL2013-11-04
10989SUPPL2009-07-23
13138SUPPL2009-07-15
33269SUPPL2009-04-16
13137SUPPL2009-04-09
587SUPPL2001-06-12