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FDA Approval

Tranylcypromine Sulfate

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

FDA Approval Summary

Company
Actavis Pharma, Inc.
DUNS: 119723554
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.

Tranylcypromine Sulfate

Product Details

NDC Product Code
0591-5590
Application Number
NDA012342
Marketing Category
NDA authorized generic (C73605)
Route of Administration
ORAL
Effective Date
March 1, 2021
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
D&C RED NO. 7Inactive
Code: ECW0LZ41X8Class: IACT
Code: 7ZAT6ES870Class: ACTIMQuantity: 10 mg in 1 1
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
LACTOSEInactive
Code: J2B2A4N98GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
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