Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Novitium Pharma LLC
Novitium Pharma LLC
080301870
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
70954-538Application Number
ANDA206856Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 18, 2021TranylcypromineActive
Code: 7ZAT6ES870Class: ACTIMQuantity: 10 mg in 1 1
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311Class: IACT
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YMClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT