FDA.reportPublic FDA data

Application 202342

Type
NDA
Sponsor
BELCHER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESOMEPRAZOLE STRONTIUMESOMEPRAZOLE STRONTIUMCAPSULE, DELAYED RELEASE;ORAL24.65MGYesNo
002ESOMEPRAZOLE STRONTIUMESOMEPRAZOLE STRONTIUMCAPSULE, DELAYED RELEASE;ORAL49.3MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52246-400ESOMEPRAZOLE STRONTIUMesomeprazole strontiumParaPRO LLCNDACurrent
53746-955Esomeprazole strontiumEsomeprazole strontiumAmneal Pharmaceuticals of New York LLCNDACurrent
53746-955Esomeprazole strontiumEsomeprazole strontiumAmneal Pharmaceuticals of New York LLCNDACurrent
53746-955Esomeprazole strontiumEsomeprazole strontiumAmneal Pharmaceuticals, LLCNDACurrent
53746-957Esomeprazole strontiumEsomeprazole strontiumAmneal Pharmaceuticals of New York LLCNDACurrent
53746-957Esomeprazole strontiumEsomeprazole strontiumAmneal Pharmaceuticals of New York LLCNDACurrent
53746-957Esomeprazole strontiumEsomeprazole strontiumAmneal Pharmaceuticals, LLCNDACurrent
65162-955Esomeprazole strontiumEsomeprazole strontiumAmneal Pharmaceuticals of New York, LLCNDACurrent
65162-955Esomeprazole strontiumEsomeprazole strontiumAmneal Pharmaceuticals LLCNDACurrent
65162-955Esomeprazole strontiumEsomeprazole strontiumAmneal Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
65162-955Esomeprazole strontiumEsomeprazole strontiumAmneal Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
65162-955Esomeprazole strontiumEsomeprazole strontiumAmneal Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
65162-957Esomeprazole strontiumEsomeprazole strontiumAmneal Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
65162-957Esomeprazole strontiumEsomeprazole strontiumAmneal Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
65162-957Esomeprazole strontiumEsomeprazole strontiumAmneal Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
65162-957Esomeprazole strontiumEsomeprazole strontiumAmneal Pharmaceuticals of New York, LLCNDACurrent
65162-957Esomeprazole strontiumEsomeprazole strontiumAmneal Pharmaceuticals LLCNDACurrent
69336-129Esomeprazole strontiumEsomeprazole strontiumSterling-Knight Pharmaceuticals, LLCNDA AUTHORIZED GENERICCurrent
70849-200ESOMEPRAZOLE STRONTIUMesomeprazole strontiumR2 Pharma, LLCNDACurrent
70849-400ESOMEPRAZOLE STRONTIUMesomeprazole strontiumR2 Pharma, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70490SUPPL2022-03-11
70489SUPPL2022-03-11
70431SUPPL2022-03-07
65428SUPPL2020-12-01
65394SUPPL2020-11-30
65393SUPPL2020-11-30
54585SUPPL2018-06-14
54534SUPPL2018-06-12
54533SUPPL2018-06-12
52256SUPPL2018-02-01
45645SUPPL2016-10-26
19324SUPPL2014-12-29
32237SUPPL2014-12-23
43396ORIG2013-11-13
19323ORIG2013-08-09
10028ORIG2013-08-08
10029ORIG2013-05-01