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.
Lansoprazole
Product Details
NDC Product Code
63629-2341Application Number
ANDA203203Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 5, 2021LansoprazoleActive
Code: 0K5C5T2QPGClass: ACTIBQuantity: 30 mg in 1 1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NAClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT