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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
March 3, 2023
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
10135-739
Application Number
ANDA206856
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 3, 2023
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YMClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Code: 7ZAT6ES870Class: ACTIMQuantity: 10 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311Class: IACT
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