Famotidine Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
App Pharmaceuticals, Llc (2015-06-05)
Oldest Current Product
2001-03-15
License(s)
ANDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
INJECTABLE SOLUTION\FAMOTIDINE
FDAOB
INJECTION\INJECTION\FAMOTIDINE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\FAMOTIDINE
INTRAVENOUS\INJECTION\FAMOTIDINE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\FAMOTIDINE
INTRAVENOUS\INJECTION\FAMOTIDINE

product(s) by strength(s)

famotidine 0.4 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003385197ANDABaxter Healthcare Corporation2001-05-10FAMOTIDINEINTRAVENOUSINJECTION, SOLUTIONANDA07559197c33213-f415-4718-8466-9aa50371af70

famotidine 10 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690121ANDAPfizer Labs2011-05-10FAMOTIDINEINTRAVENOUSINJECTION, SOLUTIONANDA0786421893ed5d-eddc-49ea-94d0-b839e0b1bfc9
2000690125ANDAPfizer Labs2011-05-10FAMOTIDINEINTRAVENOUSINJECTION, SOLUTIONANDA0786411893ed5d-eddc-49ea-94d0-b839e0b1bfc9
3000690126ANDAPfizer Labs2011-05-10FAMOTIDINEINTRAVENOUSINJECTION, SOLUTIONANDA0786411893ed5d-eddc-49ea-94d0-b839e0b1bfc9
4006416021ANDAWest-Ward Pharmaceuticals Corp.2001-04-16FAMOTIDINEINTRAVENOUSINJECTIONANDA0754881fdf16e5-145d-4c19-a318-fc6c10794b50
5006416022ANDAWest-Ward Pharmaceuticals Corp.2001-04-16FAMOTIDINEINTRAVENOUSINJECTIONANDA0754861fdf16e5-145d-4c19-a318-fc6c10794b50
6006416023ANDAWest-Ward Pharmaceuticals Corp.2001-04-16FAMOTIDINEINTRAVENOUSINJECTIONANDA0754881fdf16e5-145d-4c19-a318-fc6c10794b50
7633230738ANDAApp Pharmaceuticals, Llc2001-07-19FAMOTIDINEINTRAVENOUSINJECTION, SOLUTIONANDA0757095995d726-f3f8-4c2d-af19-1b12e3f769c6
8633230739ANDAApp Pharmaceuticals, Llc2001-03-15FAMOTIDINEINTRAVENOUSINJECTION, SOLUTIONANDA075813aeb27cea-1ff7-4a6e-93f1-d4c4dac5faa7, ce533636-cc9b-45d0-87a6-5390377ff28a
9674570433ANDAMylan Institutional Llc2008-06-26FAMOTIDINEINTRAVENOUSINJECTIONANDA078642e3b13e23-122b-4bd4-95cf-b5a14b7afc05

famotidine 2 mg/ml injectable solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1525330172UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2014-06-11FAMOTIDINEINTRAVENOUSINJECTION, SOLUTION36a915cd-75ae-40b8-b174-026d49ea23d7

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075486FAMOTIDINE PRESERVATIVE FREEEUROHEALTH INTERNATIONAL SARL2001-04-16ANDA075486_001
2ANDA075488FAMOTIDINEEUROHEALTH INTERNATIONAL SARL2001-04-16ANDA075488_001
3ANDA075591FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINERBAXTER HEALTHCARE CORP2001-05-10ANDA075591_001
4ANDA075622FAMOTIDINE PRESERVATIVE FREEBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2001-04-16ANDA075622_001
5ANDA075651FAMOTIDINEBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2001-04-16ANDA075651_001
6ANDA075669FAMOTIDINE PRESERVATIVE FREETrueHOSPIRA INC2001-04-16ANDA075669_001
7ANDA075684FAMOTIDINEBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2001-04-16ANDA075684_001
8ANDA075705FAMOTIDINETrueHOSPIRA INC2001-04-16ANDA075705_001
9ANDA075707FAMOTIDINETrueAPOTHECON INC DIV BRISTOL MYERS SQUIBB2001-04-16ANDA075707_001
10ANDA075708FAMOTIDINE PRESERVATIVE FREETrueAPOTHECON INC DIV BRISTOL MYERS SQUIBB2001-04-16ANDA075708_001
11ANDA075709FAMOTIDINEFRESENIUS KABI USA LLC2001-04-16ANDA075709_001
12ANDA075729FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINERTrueABBVIE INC2001-12-17ANDA075729_001
13ANDA075789FAMOTIDINE PRESERVATIVE FREETrueHIKMA MAPLE LTD2002-04-30ANDA075789_001
14ANDA075799FAMOTIDINETrueEUROHEALTH INTERNATIONAL SARL2002-04-30ANDA075799_001
15ANDA075813FAMOTIDINE PRESERVATIVE FREEFRESENIUS KABI USA LLC2001-04-16ANDA075813_001
16ANDA075825FAMOTIDINE PRESERVATIVE FREEBEDFORD LABORATORIES2001-04-17ANDA075825_001
17ANDA075870FAMOTIDINETrueHOSPIRA WORLDWIDE, INC2001-11-23ANDA075870_001
18ANDA075905FAMOTIDINETrueHOSPIRA INC2001-11-23ANDA075905_001
19ANDA075942FAMOTIDINETrueAPOTEX INC2002-08-02ANDA075942_001
20ANDA076322FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK)TrueAPOTEX INC2002-11-27ANDA076322_001
21ANDA076324FAMOTIDINE PRESERVATIVE FREETrueAPOTEX INC2002-11-27ANDA076324_001
22ANDA078641FAMOTIDINEMYLAN LABORATORIES LTD2008-06-25ANDA078641_001
23ANDA078642FAMOTIDINE PRESERVATIVE FREEMYLAN LABORATORIES LTD2008-06-25ANDA078642_001
24NDA019510PEPCIDTrueMERCK RESEARCH LABORATORIES DIV MERCK CO INC1986-11-04NDA019510_001, NDA019510_004
25NDA020249PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINERTrueMERCK SHARP AND DOHME CORP1994-02-18NDA020249_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA075486_001RXFAMOTIDINE (10MG/ML)INJECTIONTrueAP2001-04-16FAMOTIDINE PRESERVATIVE FREE
2ANDA075488_001RXFAMOTIDINE (10MG/ML)INJECTIONTrueAP2001-04-16FAMOTIDINE
3ANDA075591_001RXFAMOTIDINE (0.4MG/ML)INJECTIONTrueAP2001-05-10FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER
4ANDA075622_001RXFAMOTIDINE (10MG/ML)INJECTIONFalseAP2001-04-16FAMOTIDINE PRESERVATIVE FREE
5ANDA075651_001RXFAMOTIDINE (10MG/ML)INJECTIONFalseAP2001-04-16FAMOTIDINE
6ANDA075669_001discontinuedFAMOTIDINE (10MG/ML)INJECTIONFalse2001-04-16FAMOTIDINE PRESERVATIVE FREE
7ANDA075684_001RXFAMOTIDINE (10MG/ML)INJECTIONFalseAP2001-04-16FAMOTIDINE
8ANDA075705_001discontinuedFAMOTIDINE (10MG/ML)INJECTIONFalse2001-04-16FAMOTIDINE
9ANDA075707_001discontinuedFAMOTIDINE (10MG/ML)INJECTIONFalse2001-04-16FAMOTIDINE
10ANDA075708_001discontinuedFAMOTIDINE (10MG/ML)INJECTIONFalse2001-04-16FAMOTIDINE PRESERVATIVE FREE
11ANDA075709_001RXFAMOTIDINE (10MG/ML)INJECTIONFalseAP2001-04-16FAMOTIDINE
12ANDA075729_001discontinuedFAMOTIDINE (0.4MG/ML)INJECTIONFalse2001-12-17FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER
13ANDA075789_001discontinuedFAMOTIDINE (10MG/ML)INJECTIONFalse2002-04-30FAMOTIDINE PRESERVATIVE FREE
14ANDA075799_001discontinuedFAMOTIDINE (10MG/ML)INJECTIONFalse2002-04-30FAMOTIDINE
15ANDA075813_001RXFAMOTIDINE (10MG/ML)INJECTIONFalseAP2001-04-16FAMOTIDINE PRESERVATIVE FREE
16ANDA075825_001RXFAMOTIDINE (10MG/ML)INJECTIONFalseAP2001-04-17FAMOTIDINE PRESERVATIVE FREE
17ANDA075870_001discontinuedFAMOTIDINE (10MG/ML)INJECTIONFalse2001-11-23FAMOTIDINE
18ANDA075905_001discontinuedFAMOTIDINE (10MG/ML)INJECTIONFalse2001-11-23FAMOTIDINE
19ANDA075942_001discontinuedFAMOTIDINE (10MG/ML)INJECTIONFalse2002-08-02FAMOTIDINE
20ANDA076322_001discontinuedFAMOTIDINE (10MG/ML)INJECTIONFalse2002-11-27FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK)
21ANDA076324_001discontinuedFAMOTIDINE (10MG/ML)INJECTIONFalse2002-11-27FAMOTIDINE PRESERVATIVE FREE
22ANDA078641_001RXFAMOTIDINE (10MG/ML)INJECTIONFalseAP2008-06-25FAMOTIDINE
23ANDA078642_001RXFAMOTIDINE (10MG/ML)INJECTIONFalseAP2008-06-25FAMOTIDINE PRESERVATIVE FREE
24NDA019510_001discontinuedFAMOTIDINE (10MG/ML)INJECTIONFalse1986-11-04PEPCID
25NDA019510_004discontinuedFAMOTIDINE (10MG/ML)INJECTIONFalse1986-11-04PEPCID
26NDA020249_001discontinuedFAMOTIDINE (0.4MG/ML)INJECTIONFalse1994-02-18PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11893ed5d-eddc-49ea-94d0-b839e0b1bfc9 (view SPL)FAMOTIDINE INJECTION, USPprescriptionHuman PrescriptionPfizer LabsANALYSIS, MANUFACTURE, PACK, STERILIZE2013-07-246000690121, 000690125, 000690126
21fdf16e5-145d-4c19-a318-fc6c10794b50 (view SPL)Famotidine Injection, USPprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE2012-01-251006416021, 006416022, 006416023
336a915cd-75ae-40b8-b174-026d49ea23d7 (view SPL)Famotidine 2 mg/mL in 0.9% Sodium Chloride 10 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2014-06-163525330172
45995d726-f3f8-4c2d-af19-1b12e3f769c6 (view SPL)Famotidine Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2011-08-231633230738
597c33213-f415-4718-8466-9aa50371af70 (view SPL)Famotidine Injection in GALAXY Plastic Container (PL 2501)Rx OnlyprescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-04-068003385197
6aeb27cea-1ff7-4a6e-93f1-d4c4dac5faa7 (view SPL)Famotidine Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2011-08-231633230739
7ce533636-cc9b-45d0-87a6-5390377ff28a (view SPL)Famotidine Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-06-051633230739
8e3b13e23-122b-4bd4-95cf-b5a14b7afc05 (view SPL)FAMOTIDINE INJECTION, USPprescriptionHuman PrescriptionMylan Institutional LlcAnalysis, Label, Manufacture, Pack, Sterilize2014-02-252674570433

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