TRANYLCYPROMINE SULFATE
These highlights do not include all the information needed to use TRANYLCYPROMINE SULFATE TABLETS safely and effectively. See full prescribing information for TRANYLCYPROMINE SULFATE TABLETS. TRANYLCYPROMINE SULFATE USP tablets, for oral use Initial U.S. Approval: 1961
Approved
Approval ID
accef599-6ead-4faa-8208-61e37eab908b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 3, 2022
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tranylcypromine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-032
Application NumberANDA040640
Product Classification
M
Marketing Category
C73584
G
Generic Name
tranylcypromine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2019
FDA Product Classification
INGREDIENTS (11)
TRANYLCYPROMINE SULFATEActive
Quantity: 10 mg in 1 1
Code: 7ZAT6ES870
Classification: ACTIM
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT