empagliflozin / Metformin Oral Tablet

Brand(s)
Synjardy
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Boehringer Ingelheim Pharmaceuticals, Inc. (2015-08-31)
Oldest Current Product
2015-08-26
License(s)
NDA
RxNORM
ORAL TABLET\EMPAGLIFLOZIN:METFORMIN
FDAOB
ORAL\TABLET\EMPAGLIFLOZIN: METFORMIN HYDROCHLORIDE
SPL Active
ORAL\TABLET\EMPAGLIFLOZIN: METFORMIN HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\EMPAGLIFLOZIN: METFORMIN

product(s) by strength(s)

empagliflozin 12.5 mg / metformin hydrochloride 1000 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970168SynjardyNDABoehringer Ingelheim Pharmaceuticals, Inc.2015-08-26EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDEORALTABLETNDA2061110fdd0255-0055-65f3-b2c0-db8fbb87beae

empagliflozin 12.5 mg / metformin hydrochloride 500 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970180SynjardyNDABoehringer Ingelheim Pharmaceuticals, Inc.2015-08-26EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDEORALTABLETNDA2061110fdd0255-0055-65f3-b2c0-db8fbb87beae

empagliflozin 5 mg / metformin hydrochloride 1000 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970175SynjardyNDABoehringer Ingelheim Pharmaceuticals, Inc.2015-08-26EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDEORALTABLETNDA2061110fdd0255-0055-65f3-b2c0-db8fbb87beae

empagliflozin 5 mg / metformin hydrochloride 500 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970159SynjardyNDABoehringer Ingelheim Pharmaceuticals, Inc.2015-08-26EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDEORALTABLETNDA2061110fdd0255-0055-65f3-b2c0-db8fbb87beae

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA206111SYNJARDYBOEHRINGER INGELHEIM PHARMACEUTICALS INC2015-08-26p7579449
p7713938, SUBSTANCE
NEW CHEMICAL ENTITY [2019-08-01]
NEW PRODUCT [2018-08-26]
NDA206111_001, NDA206111_002, NDA206111_003, NDA206111_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA206111_001RXEMPAGLIFLOZIN (5MG), METFORMIN HYDROCHLORIDE (500MG)ORALTABLETFalse2015-08-26SYNJARDY
2NDA206111_002RXEMPAGLIFLOZIN (5MG), METFORMIN HYDROCHLORIDE (1GM)ORALTABLETFalse2015-08-26SYNJARDY
3NDA206111_003RXMETFORMIN HYDROCHLORIDE (500MG), EMPAGLIFLOZIN (12.5MG)ORALTABLETFalse2015-08-26SYNJARDY
4NDA206111_004RXMETFORMIN HYDROCHLORIDE (1GM), EMPAGLIFLOZIN (12.5MG)ORALTABLETTrue2015-08-26SYNJARDY

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7579449 (view patent)2025-11-05NDA206111, NDA204629, NDA206073empagliflozin / Linagliptin Oral Tablet
2p7713938 (view patent)2027-04-15NDA206111, NDA204629, NDA206073empagliflozin / Linagliptin Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10fdd0255-0055-65f3-b2c0-db8fbb87beae (view SPL)These highlights do not include all the information needed to use SYNJARDY safely and effectively. See full prescribing information for SYNJARDY. SYNJARDY (empagliflozin and metformin hydrochloride) tablets, for oral useInitial U.S. Approval: 2015prescriptionHuman PrescriptionBoehringer Ingelheim Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-08-311005970159, 005970168, 005970175, 005970180

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