Famotidine Chewable Tablet

Brand(s)
Pepcid
Category(s)
otc
SPL Type(s)
Human OTC
Master SPL
Mcneil Consumer Pharmaceuticals Co. (2012-10-18)
Oldest Current Product
2008-02-01
License(s)
NDA
RxNORM
CHEWABLE TABLET\FAMOTIDINE
FDAOB
ORAL\TABLET, CHEWABLE\FAMOTIDINE
SPL Active
ORAL\TABLET, CHEWABLE\FAMOTIDINE
SPL Moiety
ORAL\TABLET, CHEWABLE\FAMOTIDINE

product(s) by strength(s)

famotidine 20 mg chewable tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1168370854PepcidNDAMcneil Consumer Pharmaceuticals Co.2008-02-01FAMOTIDINEORALTABLET, CHEWABLENDA0208017ac09d0a-9bce-447b-b3a1-3296687f12e6

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA075715FAMOTIDINEL PERRIGO CO2003-08-22ANDA075715_001
2NDA020801PEPCID ACJOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION1998-09-24p6814978, SUBSTANCE
p5667794
p5854267, PREVENTING HEARTBURN EPISODES FOLLOWING INGESTION OF HEARTBURN-INDUCING FOOD/BEVERAGE
NDA020801_001, NDA020801_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA075715_001OTCFAMOTIDINE (10MG)ORALTABLET, CHEWABLEFalse2003-08-22FAMOTIDINE
2NDA020801_001discontinuedFAMOTIDINE (10MG)ORALTABLET, CHEWABLEFalse1998-09-24PEPCID AC
3NDA020801_002OTCFAMOTIDINE (20MG)ORALTABLET, CHEWABLETrue2007-12-17PEPCID AC

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5667794 (view patent)2015-05-02NDA020801
2p5854267 (view patent)2015-12-29NDA020801, NDA020325, NDA020902Famotidine Oral Tablet
3p6814978 (view patent)2021-08-26NDA020801, NDA020448, NDA020958Calcium Carbonate / Famotidine / Magnesium Hydroxide Chewable Tablet

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
17ac09d0a-9bce-447b-b3a1-3296687f12e6 (view SPL)Pepcid ACEZ CHEWSotcHuman OTCMcneil Consumer Pharmaceuticals Co.2012-10-182168370854

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