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.
Lansoprazole
Product Details
NDC Product Code
68788-6390Application Number
ANDA091269Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 10, 2023ammoniaInactive
Code: 5138Q19F1XClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
magnesium carbonateInactive
Code: 0E53J927NAClass: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14Class: IACT
LansoprazoleActive
Code: 0K5C5T2QPGClass: ACTIBQuantity: 15 mg in 1 1
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8JClass: IACT
propylene glycolInactive
Code: 6DC9Q167V3Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
starch, cornInactive
Code: O8232NY3SJClass: IACT
shellacInactive
Code: 46N107B71OClass: IACT
raw sugarInactive
Code: 8M707QY5GHClass: IACT
sucroseInactive
Code: C151H8M554Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
ferric oxide redInactive
Code: 1K09F3G675Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
ferric oxide yellowInactive
Code: EX438O2MRTClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
sodium lauryl sulfateInactive
Code: 368GB5141JClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT