Application 017090

Type
NDA
Sponsor
SPECGX LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOFRANIL-PMIMIPRAMINE PAMOATECAPSULE;ORALEQ 75MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002TOFRANIL-PMIMIPRAMINE PAMOATECAPSULE;ORALEQ 150MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003TOFRANIL-PMIMIPRAMINE PAMOATECAPSULE;ORALEQ 125MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004TOFRANIL-PMIMIPRAMINE PAMOATECAPSULE;ORALEQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10967SUPPL2014-07-29
548SUPPL2014-07-29
13086SUPPL2014-07-11
10966SUPPL2014-07-11
23102ORIG2012-10-29
547SUPPL2012-10-29
10965SUPPL2012-10-26
546SUPPL2007-07-24
10964SUPPL2007-07-16
23535ORIG2007-05-09
33226SUPPL2005-01-13
13085SUPPL2005-01-13
545SUPPL2004-03-28