Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Preferred Pharmaceuticals Inc.
791119022
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals Inc.
791119022
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sucralfate
Product Details
NDC Product Code
68788-8316Application Number
NDA018333Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
September 25, 2023MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SucralfateActive
Code: XX73205DH5Class: ACTIBQuantity: 1 g in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQYClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT