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
8ab1c887-76fb-44ca-9999-4eefd3778cfc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 18, 2021
Manufacturers
FDA
Novitium Pharma LLC
DUNS: 080301870
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 Code70954-538
Application NumberANDA206856
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tranylcypromine
Product Specifications
Route of AdministrationORAL
Effective DateJune 18, 2021
FDA Product Classification
INGREDIENTS (14)
TRANYLCYPROMINE SULFATEActive
Quantity: 10 mg in 1 1
Code: 7ZAT6ES870
Classification: ACTIM
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YM
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT