Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Par Pharmaceutical Inc.
092733690
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TRANYLCYPROMINE SULFATE
Product Details
NDC Product Code
49884-032Application Number
ANDA040640Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 19, 2019TranylcypromineActive
Code: 7ZAT6ES870Class: ACTIMQuantity: 10 mg in 1 1
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT