miglitol Oral Tablet

Brand(s)
Glyset
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmacia And Upjohn Company (2014-01-02)
Oldest Current Product
1996-12-18
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\MIGLITOL
FDAOB
ORAL\TABLET\MIGLITOL
SPL Active
ORAL\TABLET, COATED\MIGLITOL
ORAL\TABLET, FILM COATED\MIGLITOL
SPL Moiety
ORAL\TABLET, COATED\MIGLITOL
ORAL\TABLET, FILM COATED\MIGLITOL

product(s) by strength(s)

miglitol 100 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000095014GlysetNDAPharmacia And Upjohn Company1996-12-18MIGLITOLORALTABLET, FILM COATEDNDA02068275711d16-2d27-476e-a312-d5af448a0e25

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1763330127ANDAOrient Pharma Co., Ltd.2015-07-31MIGLITOLORALTABLET, COATEDANDA203965192e6ed7-9e8c-4772-9e3b-5912a1c63a31

miglitol 25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000095012GlysetNDAPharmacia And Upjohn Company1996-12-18MIGLITOLORALTABLET, FILM COATEDNDA02068275711d16-2d27-476e-a312-d5af448a0e25

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1763330125ANDAOrient Pharma Co., Ltd.2015-07-31MIGLITOLORALTABLET, COATEDANDA203965192e6ed7-9e8c-4772-9e3b-5912a1c63a31

miglitol 50 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000095013GlysetNDAPharmacia And Upjohn Company1996-12-18MIGLITOLORALTABLET, FILM COATEDNDA02068275711d16-2d27-476e-a312-d5af448a0e25

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1763330126ANDAOrient Pharma Co., Ltd.2015-07-31MIGLITOLORALTABLET, COATEDANDA203965192e6ed7-9e8c-4772-9e3b-5912a1c63a31

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA203965MIGLITOLORIENT PHARMA CO LTD2015-02-24ANDA203965_001, ANDA203965_002, ANDA203965_003
2NDA020682GLYSETPHARMACIA AND UPJOHN CO1996-12-18NDA020682_001, NDA020682_002, NDA020682_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA203965_001RXMIGLITOL (25MG)ORALTABLETFalseAB2015-02-24MIGLITOL
2ANDA203965_002RXMIGLITOL (50MG)ORALTABLETFalseAB2015-02-24MIGLITOL
3ANDA203965_003RXMIGLITOL (100MG)ORALTABLETFalseAB2015-02-24MIGLITOL
4NDA020682_001RXMIGLITOL (25MG)ORALTABLETFalseAB1996-12-18GLYSET
5NDA020682_002RXMIGLITOL (50MG)ORALTABLETFalseAB1996-12-18GLYSET
6NDA020682_003RXMIGLITOL (100MG)ORALTABLETTrueAB1996-12-18GLYSET

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1192e6ed7-9e8c-4772-9e3b-5912a1c63a31 (view SPL)Miglitol TabletsprescriptionHuman PrescriptionOrient Pharma Co., Ltd.MANUFACTURE2014-12-055763330125, 763330126, 763330127
275711d16-2d27-476e-a312-d5af448a0e25 (view SPL)Glyset (miglitol) tabletsprescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-01-028000095012, 000095013, 000095014

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII