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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
Lannett Company, Inc.
DUNS: 002277481
Effective Date
July 7, 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
0527-3010
Application Number
ANDA213503
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 7, 2022
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM PALMITOSTEARATEInactive
Code: R4OXA9G5BVClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CARMINIC ACIDInactive
Code: CID8Z8N95NClass: IACT
Code: 7ZAT6ES870Class: ACTIMQuantity: 10 mg in 1 1
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