PARNATE
These highlights do not include all the information needed to use PARNATE safely and effectively. See full prescribing information for PARNATE. Parnate(tranylcypromine) tablets, for oral use Initial U.S. Approval: 1961
Approved
Approval ID
b72d8187-dfcc-4ea0-b5e9-c0be95b69a27
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 27, 2021
Manufacturers
FDA
Concordia Pharmaceuticals Inc.
DUNS: 815240092
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 Code59212-447
Application NumberNDA012342
Product Classification
M
Marketing Category
C73594
G
Generic Name
tranylcypromine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 1, 2021
FDA Product Classification
INGREDIENTS (16)
TRANYLCYPROMINE SULFATEActive
Quantity: 10 mg in 1 1
Code: 7ZAT6ES870
Classification: ACTIM
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
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
D&C RED NO. 7Inactive
Code: ECW0LZ41X8
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT