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FDA Approval

Tranylcypromine

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

FDA Approval Summary

Company
Effective Date
October 15, 2022
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

Product Details

NDC Product Code
43547-655
Application Number
ANDA213503
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 7, 2022
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM PALMITOSTEARATEInactive
Code: R4OXA9G5BVClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
CARMINIC ACIDInactive
Code: CID8Z8N95NClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Code: 7ZAT6ES870Class: ACTIMQuantity: 10 mg in 1 1
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