Phenytoin Chewable Tablet

Brand(s)
Dilantin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Parke-Davis Div Of Pfizer Inc (2015-08-25)
Oldest Current Product
1979-02-26
License(s)
ANDA
RxNORM
CHEWABLE TABLET\PHENYTOIN
FDAOB
ORAL\TABLET, CHEWABLE\PHENYTOIN
SPL Active
ORAL\TABLET, CHEWABLE\PHENYTOIN
SPL Moiety
ORAL\TABLET, CHEWABLE\PHENYTOIN

product(s) by strength(s)

phenytoin 50 mg chewable tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000710007DilantinANDAParke-Davis Div Of Pfizer Inc1979-02-26PHENYTOINORALTABLET, CHEWABLEANDA084427ca119a89-2394-4d34-8078-cd1fa4e8e2f1
2003783850ANDAMylan Pharmaceuticals Inc.2012-12-26PHENYTOINORALTABLET, CHEWABLEANDA20069115d32f84-14f6-49a6-9bad-d7f4b14eaf14
3516724146ANDATaro Pharmaceuticals U.S.A., Inc.2014-04-17PHENYTOINORALTABLET, CHEWABLEANDA20056578b38e7b-1460-4adc-b738-320ffa6259c2
4597625210ANDAGreenstone Llc2012-12-27PHENYTOINORALTABLET, CHEWABLEANDA0844270c9321ae-cc4d-45f0-87d3-e2a5b4f60fde
5647200212ANDACorepharma, Llc2014-12-08PHENYTOINORALTABLET, CHEWABLEANDA0408846501266c-b255-4fd3-9142-0437ca8f7c5e

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157764ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2012-12-26PHENYTOINORALTABLET, CHEWABLE003783850ANDA200691708599c8-6d55-4765-94b6-0c8229dd1379
2493490495DilantinANDARemedyrepack Inc.2011-08-18PHENYTOINORALTABLET, CHEWABLE000710007ANDA08442705ff10d5-f1a4-47f0-ba60-7369152afb16
3510790129ANDAMylan Institutional Inc.2012-12-18PHENYTOINORALTABLET, CHEWABLE003783850ANDA2006914e97b46f-015e-492a-ae84-d7049f6b91d9
4551542233ANDACardinal Health2012-12-26PHENYTOINORALTABLET, CHEWABLE003783850ANDA20069134a311f4-e25e-45af-be6b-42525b66b731
5551542416DilantinANDACardinal Health1979-02-26PHENYTOINORALTABLET, CHEWABLE000710007ANDA08442795d29970-f8ef-4799-b489-ebe2285de4de
6606870156ANDAAmerican Health Packaging2015-09-01PHENYTOINORALTABLET, CHEWABLE516724146ANDA200565352007dd-0587-4597-8338-c13eda4c5d63

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA040884PHENYTOINCOREPHARMA LLC2014-11-28ANDA040884_001
2ANDA084427DILANTINPFIZER PHARMACEUTICALS LTDANDA084427_001
3ANDA200565PHENYTOINTARO PHARMACEUTICALS USA INC2014-04-17ANDA200565_001
4ANDA200691PHENYTOINMYLAN PHARMACEUTICALS INC2012-12-26ANDA200691_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040884_001RXPHENYTOIN (50MG)ORALTABLET, CHEWABLEFalseAB2014-11-28PHENYTOIN
2ANDA084427_001RXPHENYTOIN (50MG)ORALTABLET, CHEWABLETrueABDILANTIN
3ANDA200565_001RXPHENYTOIN (50MG)ORALTABLET, CHEWABLEFalseAB2014-04-17PHENYTOIN
4ANDA200691_001RXPHENYTOIN (50MG)ORALTABLET, CHEWABLEFalseAB2012-12-26PHENYTOIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
105ff10d5-f1a4-47f0-ba60-7369152afb16 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-08-181493490495
20c9321ae-cc4d-45f0-87d3-e2a5b4f60fde (view SPL)INFATABS Phenytoin (Phenytoin Chewable Tablets, USP)prescriptionHuman PrescriptionGreenstone LlcANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-07-1511597625210
315d32f84-14f6-49a6-9bad-d7f4b14eaf14 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-05-305003783850
434a311f4-e25e-45af-be6b-42525b66b731 (view SPL)prescriptionHuman PrescriptionCardinal HealthREPACK2015-04-231551542233
5352007dd-0587-4597-8338-c13eda4c5d63 (view SPL)Phenytoin Chewable Tablets, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-08-311606870156
64e97b46f-015e-492a-ae84-d7049f6b91d9 (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2015-02-062510790129
76501266c-b255-4fd3-9142-0437ca8f7c5e (view SPL)Phenytoin Chewable Tablets, USP50 mg Rx OnlyprescriptionHuman PrescriptionCorepharma, Llc2014-12-085647200212
8708599c8-6d55-4765-94b6-0c8229dd1379 (view SPL)Phenytoin Chewable TabsprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2015-04-061006157764
978b38e7b-1460-4adc-b738-320ffa6259c2 (view SPL)Phenytoin Chewable Tablets USP, 50 mgprescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2015-09-115516724146
1095d29970-f8ef-4799-b489-ebe2285de4de (view SPL)INFATABS Dilantin (Phenytoin Tablets, USP)prescriptionHuman PrescriptionCardinal HealthREPACK2013-04-051551542416
11ca119a89-2394-4d34-8078-cd1fa4e8e2f1 (view SPL)INFATABS Dilantin (Phenytoin Chewable Tablets, USP)prescriptionHuman PrescriptionParke-Davis Div Of Pfizer IncANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-08-2524000710007

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