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 delayed release
Product Details
NDC Product Code
72162-2239Application Number
ANDA202666Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 19, 2024METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
DexlansoprazoleActive
Code: UYE4T5I70XClass: ACTIBQuantity: 60 mg in 1 1
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NAClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive
Code: 5KY68S2577Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT