Tranylcypromine
These highlights do not include all the information needed to use TRANYLCYPROMINE TABLETS safely and effectively. See full prescribing information for TRANYLCYPROMINE TABLETS. TRANYLCYPROMINE tablets, for oral use Initial U.S. Approval: 1961
Approved
Approval ID
cfea09dc-2c5e-46ba-a2c3-e7e57c822974
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 7, 2022
Manufacturers
FDA
Lannett Company, Inc.
DUNS: 002277481
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TRANYLCYPROMINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0527-3010
Application NumberANDA213503
Product Classification
M
Marketing Category
C73584
G
Generic Name
TRANYLCYPROMINE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2022
FDA Product Classification
INGREDIENTS (11)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM PALMITOSTEARATEInactive
Code: R4OXA9G5BV
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CARMINIC ACIDInactive
Code: CID8Z8N95N
Classification: IACT
TRANYLCYPROMINE SULFATEActive
Quantity: 10 mg in 1 1
Code: 7ZAT6ES870
Classification: ACTIM