Chemet
CHEMET® (succimer) Capsule 100 mg R only
Approved
Approval ID
62035612-9505-3a3f-1ac8-e2dbd711d24e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2023
Manufacturers
FDA
Recordati Rare Diseases, Inc.
DUNS: 181699406
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
succimer
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55292-201
Application NumberNDA019998
Product Classification
M
Marketing Category
C73594
G
Generic Name
succimer
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2023
FDA Product Classification
INGREDIENTS (8)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SUCCIMERActive
Quantity: 100 mg in 1 1
Code: DX1U2629QE
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT