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FDA Approval

PARNATE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
August 27, 2021
Labeling Type
Human Prescription Drug Label
Tranylcypromine(10 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

PARNATE

Product Details

NDC Product Code
59212-447
Application Number
NDA012342
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
March 1, 2021
Code: 7ZAT6ES870Class: ACTIMQuantity: 10 mg in 1 1
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
D&C RED NO. 7Inactive
Code: ECW0LZ41X8Class: IACT
LACTOSEInactive
Code: J2B2A4N98GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
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