Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
CALVIN, SCOTT AND COMPANY, INCORPORATED
CALVIN, SCOTT AND COMPANY, INCORPORATED
073404626
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PHENDIMETRAZINE TARTRATE
Product Details
NDC Product Code
17224-501Application Number
ANDA085588Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 9, 2019STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
PhendimetrazineActive
Code: 6985IP0T80Class: ACTIBQuantity: 35 mg in 1 1
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT