Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexlansoprazole
Product Details
NDC Product Code
72162-2244Application Number
ANDA202294Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 29, 2024DexlansoprazoleActive
Code: UYE4T5I70XClass: ACTIBQuantity: 30 mg in 1 1
SUCROSEInactive
Code: C151H8M554Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CALCIUM HYDROXIDEInactive
Code: PF5DZW74VNClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
LAURYL SULFATEInactive
Code: DIQ16UC154Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive
Code: 5KY68S2577Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT