Famotidine Oral Suspension

Brand(s)
Pepcid
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Paddock Laboratories, Llc (2010-11-11)
Oldest Current Product
2010-05-27
License(s)
NDA, ANDA
RxNORM
ORAL SUSPENSION\FAMOTIDINE
FDAOB
ORAL\FOR SUSPENSION\FAMOTIDINE
ORAL\SUSPENSION\FAMOTIDINE
SPL Active
ORAL\FOR SUSPENSION\FAMOTIDINE
ORAL\POWDER, FOR SUSPENSION\FAMOTIDINE
SPL Moiety
ORAL\FOR SUSPENSION\FAMOTIDINE
ORAL\POWDER, FOR SUSPENSION\FAMOTIDINE

product(s) by strength(s)

famotidine 8 mg/ml oral suspension

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005740147NDAPaddock Laboratories, Llc2010-05-28FAMOTIDINEORALPOWDER, FOR SUSPENSIONNDA01952750a26e9a-42d5-4d91-a346-57ef3a1e935f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1400320500ANDANovel Laboratories, Inc.2012-12-17FAMOTIDINEORALFOR SUSPENSIONANDA201695a6330a0d-4c67-4019-9700-7383fad7cbc7
2433860500ANDAGavis Pharmaceuticals, Llc2012-12-17FAMOTIDINEORALFOR SUSPENSIONANDA201695a0bdf4d1-8458-4e4f-95aa-bcc38c0f32f8
3681800150ANDALupin Pharmaceuticals, Inc.2010-06-29FAMOTIDINEORALPOWDER, FOR SUSPENSIONANDA0904402caaf94b-b382-4573-8614-57815776b659
4683820444ANDAZydus Pharmaceuticals (Usa) Inc.2010-05-27FAMOTIDINEORALPOWDER, FOR SUSPENSIONANDA091020a8010e10-68fd-455f-968f-d62a1c3e0ffd

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA090440FAMOTIDINELUPIN LTD2010-06-29ANDA090440_001
2ANDA091020FAMOTIDINENAVINTA LLC2010-05-27ANDA091020_001
3ANDA201695FAMOTIDINENOVEL LABORATORIES INC2012-12-17ANDA201695_001
4ANDA201995FAMOTIDINEHI-TECH PHARMACAL CO INC2014-05-30ANDA201995_001
5NDA019527PEPCIDSALIX PHARMACEUTICALS INC1987-02-02NDA019527_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA090440_001RXFAMOTIDINE (40MG/5ML)ORALFOR SUSPENSIONFalseAB2010-06-29FAMOTIDINE
2ANDA091020_001RXFAMOTIDINE (40MG/5ML)ORALFOR SUSPENSIONFalseAB2010-05-27FAMOTIDINE
3ANDA201695_001RXFAMOTIDINE (40MG/5ML)ORALSUSPENSIONFalseAB2012-12-17FAMOTIDINE
4ANDA201995_001RXFAMOTIDINE (40MG/5ML)ORALFOR SUSPENSIONFalseAB2014-05-30FAMOTIDINE
5NDA019527_001RXFAMOTIDINE (40MG/5ML)ORALFOR SUSPENSIONTrueAB1987-02-02PEPCID

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12caaf94b-b382-4573-8614-57815776b659 (view SPL)FAMOTIDINE FOR ORAL SUSPENSION USP40 mg/5 mLprescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.MANUFACTURE2010-02-174681800150
24f1a0b58-f7c8-485e-a317-432e1c374d2f (view SPL)Pepcid Oral SuspensionprescriptionHuman PrescriptionSalix Pharmaceuticals, Inc.2013-06-0311656490211
350a26e9a-42d5-4d91-a346-57ef3a1e935f (view SPL)FAMOTIDINE FOR ORAL SUSPENSIONprescriptionHuman PrescriptionPaddock Laboratories, LlcMANUFACTURE2010-11-111005740147
4a0bdf4d1-8458-4e4f-95aa-bcc38c0f32f8 (view SPL)Famotidine for Oral Suspension, USP GAVIS Pharmaceuticals, LLCprescriptionHuman PrescriptionGavis Pharmaceuticals, LlcANALYSIS, MANUFACTURE2013-01-081433860500
5a6330a0d-4c67-4019-9700-7383fad7cbc7 (view SPL)Famotidine for Oral Suspension, USP Novel Laboratories, Inc.prescriptionHuman PrescriptionNovel Laboratories, Inc.ANALYSIS, MANUFACTURE2013-01-084400320500
6a8010e10-68fd-455f-968f-d62a1c3e0ffd (view SPL)Rx onlyprescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.2010-05-261683820444

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