Phenytoin Oral Capsule

Brand(s)
Dilantin
Category(s)
prescription
SPL Type(s)
Human Prescription
Oldest Current Product
2008-01-30
License(s)
ANDA
RxNORM
ORAL CAPSULE\PHENYTOIN
FDAOB
ORAL\CAPSULE\PHENYTOIN SODIUM
SPL Active
ORAL\CAPSULE\PHENYTOIN SODIUM
SPL Moiety
ORAL\CAPSULE\PHENYTOIN

product(s) by strength(s)

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490471ANDARemedyrepack Inc.2013-04-09, 2013-06-24PHENYTOIN SODIUMORALCAPSULE646790720ANDA0407325b6f1dee-14c8-4c1f-8776-77a0eaaa60e0, 611237d2-e4e6-43ec-bb4e-052f86e92c76, a0663e35-fb54-4267-81eb-a7165be54465
2647250720ANDATya Pharmaceuticals2008-01-30PHENYTOIN SODIUMORALCAPSULE646790720ANDA04073273273069-249a-423e-b634-a73af6632ba3

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490355DilantinANDARemedyrepack Inc.2011-07-08PHENYTOIN SODIUMORALCAPSULE000710369ANDA0843490c2e0671-bb5e-4704-a242-83c5b9a0bbb0
2619190815ANDADirect Rx2014-01-01PHENYTOIN SODIUMORALCAPSULE651620212ANDA040765df0bf42b-ce9a-42c3-8c24-46f1ea3bd214

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040298EXTENDED PHENYTOIN SODIUMMYLAN PHARMACEUTICALS INC1998-12-28ANDA040298_001, ANDA040298_002, ANDA040298_003Folic Acid Oral Tablet
Phenytoin Extended Release Oral Capsule
2ANDA040435EXTENDED PHENYTOIN SODIUMTrueANI PHARMACEUTICALS INC2003-06-20ANDA040435_001Folic Acid Oral Tablet
Phenytoin Extended Release Oral Capsule
3ANDA040621EXTENDED PHENYTOIN SODIUMSUN PHARMACEUTICAL INDUSTRIES LTD2006-12-11ANDA040621_001Folic Acid Oral Tablet
Phenytoin Extended Release Oral Capsule
4ANDA040684EXTENDED PHENYTOIN SODIUMTARO PHARMACEUTICAL INDUSTRIES LTD2006-09-05ANDA040684_001Folic Acid Oral Tablet
Phenytoin Extended Release Oral Capsule
5ANDA040731EXTENDED PHENYTOIN SODIUMSUN PHARMACEUTICAL INDUSTRIES LTD2008-06-30ANDA040731_001, ANDA040731_002Folic Acid Oral Tablet
Phenytoin Extended Release Oral Capsule
6ANDA040732EXTENDED PHENYTOIN SODIUMTrueWOCKHARDT USA INC2008-01-30ANDA040732_001Folic Acid Oral Tablet
Phenytoin Extended Release Oral Capsule
7ANDA040759EXTENDED PHENYTOIN SODIUMTrueWOCKHARDT LTD2007-12-18ANDA040759_001Folic Acid Oral Tablet
Phenytoin Extended Release Oral Capsule
8ANDA040765EXTENDED PHENYTOIN SODIUMAMNEAL PHARMACEUTICALS NY LLC2008-11-12ANDA040765_001Folic Acid Oral Tablet
Phenytoin Extended Release Oral Capsule
9ANDA080259PROMPT PHENYTOIN SODIUMTrueANI PHARMACEUTICALS INCANDA080259_001Folic Acid Oral Tablet
Phenytoin Extended Release Oral Capsule
10ANDA080857DIPHENYLAN SODIUMTrueLANNETT CO INCANDA080857_001, ANDA080857_002Folic Acid Oral Tablet
Phenytoin Extended Release Oral Capsule
11ANDA080905PROMPT PHENYTOIN SODIUMTrueWATSON LABORATORIES INCANDA080905_001Folic Acid Oral Tablet
Phenytoin Extended Release Oral Capsule
12ANDA084349DILANTINPARKE DAVIS DIV WARNER LAMBERT COANDA084349_001, ANDA084349_002Folic Acid Oral Tablet
Phenytoin Extended Release Oral Capsule
13ANDA085435PHENYTOIN SODIUMTruePHARMERAL INCANDA085435_001Folic Acid Oral Tablet
Phenytoin Extended Release Oral Capsule
14ANDA085894PHENYTOIN SODIUMTrueWATSON LABORATORIES INCANDA085894_001Folic Acid Oral Tablet
Phenytoin Extended Release Oral Capsule
15ANDA088711PHENYTEXTrueWATSON LABORATORIES INC1984-12-21ANDA088711_001Folic Acid Oral Tablet
Phenytoin Extended Release Oral Capsule
16ANDA089441EXTENDED PHENYTOIN SODIUMTrueANI PHARMACEUTICALS INC1986-12-18ANDA089441_001Folic Acid Oral Tablet
Phenytoin Extended Release Oral Capsule
17ANDA204309PHENYTOIN SODIUMAUROBINDO PHARMA LTD2015-06-10ANDA204309_001Folic Acid Oral Tablet
Phenytoin Extended Release Oral Capsule

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040298_001RXPHENYTOIN SODIUM (100MG EXTENDED)ORALCAPSULEFalseAB1998-12-28EXTENDED PHENYTOIN SODIUM
2ANDA040298_002RXPHENYTOIN SODIUM (200MG EXTENDED)ORALCAPSULEFalseAB2001-12-06EXTENDED PHENYTOIN SODIUM
3ANDA040298_003RXPHENYTOIN SODIUM (300MG EXTENDED)ORALCAPSULETrueAB2001-12-06EXTENDED PHENYTOIN SODIUM
4ANDA040435_001discontinuedPHENYTOIN SODIUM (100MG EXTENDED)ORALCAPSULEFalse2003-06-20EXTENDED PHENYTOIN SODIUM
5ANDA040621_001RXPHENYTOIN SODIUM (100MG EXTENDED)ORALCAPSULEFalseAB2006-12-11EXTENDED PHENYTOIN SODIUM
6ANDA040684_001RXPHENYTOIN SODIUM (100MG EXTENDED)ORALCAPSULEFalseAB2006-09-05EXTENDED PHENYTOIN SODIUM
7ANDA040731_001RXPHENYTOIN SODIUM (200MG EXTENDED)ORALCAPSULEFalseAB2008-06-30EXTENDED PHENYTOIN SODIUM
8ANDA040731_002RXPHENYTOIN SODIUM (300MG EXTENDED)ORALCAPSULEFalseAB2008-06-30EXTENDED PHENYTOIN SODIUM
9ANDA040732_001discontinuedPHENYTOIN SODIUM (100MG EXTENDED)ORALCAPSULEFalse2008-01-30EXTENDED PHENYTOIN SODIUM
10ANDA040759_001discontinuedPHENYTOIN SODIUM (30MG EXTENDED)ORALCAPSULEFalse2007-12-18EXTENDED PHENYTOIN SODIUM
11ANDA040765_001RXPHENYTOIN SODIUM (100MG EXTENDED)ORALCAPSULEFalseAB2008-11-12EXTENDED PHENYTOIN SODIUM
12ANDA080259_001discontinuedPHENYTOIN SODIUM (100MG PROMPT)ORALCAPSULEFalsePROMPT PHENYTOIN SODIUM
13ANDA080857_001discontinuedPHENYTOIN SODIUM (30MG PROMPT)ORALCAPSULEFalseDIPHENYLAN SODIUM
14ANDA080857_002discontinuedPHENYTOIN SODIUM (100MG PROMPT)ORALCAPSULEFalseDIPHENYLAN SODIUM
15ANDA080905_001discontinuedPHENYTOIN SODIUM (100MG PROMPT)ORALCAPSULEFalsePROMPT PHENYTOIN SODIUM
16ANDA084349_001RXPHENYTOIN SODIUM (30MG EXTENDED)ORALCAPSULETrueABDILANTIN
17ANDA084349_002RXPHENYTOIN SODIUM (100MG EXTENDED)ORALCAPSULETrueABDILANTIN
18ANDA085435_001discontinuedPHENYTOIN SODIUM (100MG PROMPT)ORALCAPSULEFalsePHENYTOIN SODIUM
19ANDA085894_001discontinuedPHENYTOIN SODIUM (100MG PROMPT)ORALCAPSULEFalsePHENYTOIN SODIUM
20ANDA088711_001discontinuedPHENYTOIN SODIUM (100MG EXTENDED)ORALCAPSULEFalse1984-12-21PHENYTEX
21ANDA089441_001discontinuedPHENYTOIN SODIUM (100MG EXTENDED)ORALCAPSULEFalse1986-12-18EXTENDED PHENYTOIN SODIUM
22ANDA204309_001RXPHENYTOIN SODIUM (100MG EXTENDED)ORALCAPSULEFalseAB2015-06-10PHENYTOIN SODIUM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10c2e0671-bb5e-4704-a242-83c5b9a0bbb0 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-07-081493490355
25b6f1dee-14c8-4c1f-8776-77a0eaaa60e0 (view SPL)Extended Phenytoin Sodium Capsules USP, 100 mgRx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-04-091493490471
3611237d2-e4e6-43ec-bb4e-052f86e92c76 (view SPL)Extended Phenytoin Sodium Capsules USP, 100 mgRx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-04-091493490471
473273069-249a-423e-b634-a73af6632ba3 (view SPL)Extended Phenytoin Sodium Capsules USP, 100 mg Rx onlyprescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2012-07-202647250720
5a0663e35-fb54-4267-81eb-a7165be54465 (view SPL)Extended Phenytoin Sodium Capsules USP, 100 mgRx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-241493490471
6df0bf42b-ce9a-42c3-8c24-46f1ea3bd214 (view SPL)PHENYTOIN SODIUMprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-01-081619190815

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