FDA.reportPublic FDA data

Application 011909

Type
NDA
Sponsor
PARKE DAVIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002NARDILPHENELZINE SULFATETABLET;ORALEQ 15MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0071-0350NardilPhenelzine SulfateParke-Davis Div of Pfizer IncNDACurrent
0071-0350NardilPhenelzine SulfateParke-Davis Div of Pfizer IncNDACurrent
24822-119Greenstone Brand Phenelzine SulfatePHENELZINE SULFATEFarmeaNDA AUTHORIZED GENERICCurrent
24822-350Nardil Phenelzine SulfatePHENELZINE SULFATEFarmeaNDACurrent
59762-0119phenelzine sulfatePhenelzine SulfateGreenstone LLCNDACurrent
59762-0119phenelzine sulfatePhenelzine SulfateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0119phenelzine sulfatePhenelzine SulfateGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69506SUPPL2021-12-07
43584ORIG2009-11-19
293SUPPL2007-08-07
33064SUPPL2007-08-03
23530ORIG2007-05-09
10787SUPPL2007-02-21
11977SUPPL2007-02-12
11976SUPPL2005-02-23
10786SUPPL2003-09-09
292SUPPL2003-09-09