FDA.reportPublic FDA data

Application 213486

Type
ANDA
Sponsor
GRAVITI PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED REL PELLETS;ORALEQ 20MG BASENoNo
002ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED REL PELLETS;ORALEQ 40MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69844-031esomeprazole magnesiumesomeprazole magnesiumGraviti Pharmaceuticals Private LimitedANDACurrent
69844-031esomeprazole magnesiumesomeprazole magnesiumGraviti Pharmaceuticals Private LimitedANDACurrent
69844-031esomeprazole magnesiumesomeprazole magnesiumGraviti Pharmaceuticals Private LimitedANDACurrent
69844-031esomeprazole magnesiumesomeprazole magnesiumGraviti Pharmaceuticals Private LimitedANDACurrent
69844-032esomeprazole magnesiumesomeprazole magnesiumGraviti Pharmaceuticals Private LimitedANDACurrent
69844-032esomeprazole magnesiumesomeprazole magnesiumGraviti Pharmaceuticals Private LimitedANDACurrent
69844-032esomeprazole magnesiumesomeprazole magnesiumGraviti Pharmaceuticals Private LimitedANDACurrent
69844-032esomeprazole magnesiumesomeprazole magnesiumGraviti Pharmaceuticals Private LimitedANDACurrent
70377-055esomeprazole magnesiumesomeprazole magnesiumBiocon Pharma Inc.,ANDACurrent
70377-055esomeprazole magnesiumesomeprazole magnesiumBiocon Pharma Inc.,ANDACurrent
70377-055esomeprazole magnesiumesomeprazole magnesiumBiocon Pharma Inc.,ANDACurrent
70377-055esomeprazole magnesiumesomeprazole magnesiumBiocon Pharma Inc.,ANDACurrent
70377-056esomeprazole magnesiumesomeprazole magnesiumBiocon Pharma Inc.,ANDACurrent
70377-056esomeprazole magnesiumesomeprazole magnesiumBiocon Pharma Inc.,ANDACurrent
70377-056esomeprazole magnesiumesomeprazole magnesiumBiocon Pharma Inc.,ANDACurrent
70377-056esomeprazole magnesiumesomeprazole magnesiumBiocon Pharma Inc.,ANDACurrent
82009-033ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMQuallent Pharmaceuticals Health LLCANDACurrent
82009-034ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMQuallent Pharmaceuticals Health LLCANDACurrent