Metronidazole Oral Capsule

Brand(s)
Flagyl
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
G.D. Searle Llc Division Of Pfizer Inc (2015-07-27)
Oldest Current Product
1995-05-03
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\METRONIDAZOLE
FDAOB
ORAL\CAPSULE\METRONIDAZOLE
SPL Active
ORAL\CAPSULE\METRONIDAZOLE
SPL Moiety
ORAL\CAPSULE\METRONIDAZOLE

product(s) by strength(s)

metronidazole 375 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000251942FlagylNDAG.D. Searle Llc Division Of Pfizer Inc1995-05-03METRONIDAZOLEORALCAPSULENDA020334a2883ca1-5a9a-4259-9d80-46ab67274384

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1231550066ANDAHeritage Pharmaceuticals Inc.2011-08-23METRONIDAZOLEORALCAPSULEANDA0790652081b0a0-7c40-4de0-9d0d-9b5117fa0c75

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076505METRONIDAZOLETrueABLE LABORATORIES INC2003-11-13ANDA076505_001
2ANDA076522METRONIDAZOLEPAR PHARMACEUTICAL INC2004-01-29ANDA076522_001
3ANDA079065METRONIDAZOLEALEMBIC LTD2009-06-23ANDA079065_001
4NDA020334FLAGYLGD SEARLE LLC1995-05-03NDA020334_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076505_001discontinuedMETRONIDAZOLE (375MG)ORALCAPSULEFalse2003-11-13METRONIDAZOLE
2ANDA076522_001RXMETRONIDAZOLE (375MG)ORALCAPSULEFalseAB2004-01-29METRONIDAZOLE
3ANDA079065_001RXMETRONIDAZOLE (375MG)ORALCAPSULEFalseAB2009-06-23METRONIDAZOLE
4NDA020334_001RXMETRONIDAZOLE (375MG)ORALCAPSULETrueAB1995-05-03FLAGYL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12081b0a0-7c40-4de0-9d0d-9b5117fa0c75 (view SPL)Metronidazole Capsules USP 375 mgprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.MANUFACTURE2015-10-1211231550066
2a2883ca1-5a9a-4259-9d80-46ab67274384 (view SPL)FLAGYL (metronidazole) capsulesprescriptionHuman PrescriptionG.D. Searle Llc Division Of Pfizer IncAPI MANUFACTURE, MANUFACTURE, PACK2015-07-279000251942

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