Griseofulvin Oral Tablet

Brand(s)
Gris-PEG
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Oceanside Pharmaceuticals (2015-04-13)
Oldest Current Product
1975-04-16
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\GRISEOFULVIN
FDAOB
ORAL\TABLET\GRISEOFULVIN, MICROCRYSTALLINE
ORAL\TABLET\GRISEOFULVIN, MICROSIZE
ORAL\TABLET\GRISEOFULVIN, ULTRAMICROSIZE
SPL Active
ORAL\TABLET, COATED\GRISEOFULVIN
ORAL\TABLET, FILM COATED\GRISEOFULVIN
ORAL\TABLET\GRISEOFULVIN
SPL Moiety
ORAL\TABLET, COATED\GRISEOFULVIN
ORAL\TABLET, FILM COATED\GRISEOFULVIN
ORAL\TABLET\GRISEOFULVIN

product(s) by strength(s)

griseofulvin 125 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1008840763Gris-PEGNDAPedinol Pharmacal Inc.1975-04-16GRISEOFULVINORALTABLET, FILM COATEDNDA05047520aa6571-ee10-4dc1-9be9-018aa0a680fc

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1511250005ANDARiconpharma Llc.2014-01-09GRISEOFULVINORALTABLET, COATEDANDA204371993f0609-0f63-4bd5-b383-a19a00945c7e
2647200295ANDACorepharma, Llc2014-09-29GRISEOFULVINORALTABLET, COATEDANDA204371db32d4ad-28a0-4f3e-ac7b-d8c6ec72d146
3649800184ANDARising Pharmaceuticals, Inc.2012-10-23GRISEOFULVINORALTABLETANDA202545f3c468b7-9412-4f49-a7e2-9400b42c7c68
4686820519NDA AUTHORIZED GENERICOceanside Pharmaceuticals2012-12-03GRISEOFULVINORALTABLET, FILM COATEDNDA05047539ac6363-93bc-4e12-a7a7-667eafac42a5

griseofulvin 250 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1008840773Gris-PEGNDAPedinol Pharmacal Inc.1975-04-16GRISEOFULVINORALTABLET, FILM COATEDNDA05047520aa6571-ee10-4dc1-9be9-018aa0a680fc

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007815514ANDASandoz Inc2013-08-07GRISEOFULVINORALTABLETANDA09159298829d90-b289-4bec-a625-7af412a5cb2d
2511250006ANDARiconpharma Llc.2014-01-09GRISEOFULVINORALTABLET, COATEDANDA204371993f0609-0f63-4bd5-b383-a19a00945c7e
3647200296ANDACorepharma, Llc2014-09-29GRISEOFULVINORALTABLET, COATEDANDA204371db32d4ad-28a0-4f3e-ac7b-d8c6ec72d146
4649800185ANDARising Pharmaceuticals, Inc.2012-10-23GRISEOFULVINORALTABLETANDA202545f3c468b7-9412-4f49-a7e2-9400b42c7c68
5686820520NDA AUTHORIZED GENERICOceanside Pharmaceuticals2012-12-03GRISEOFULVINORALTABLET, FILM COATEDNDA05047539ac6363-93bc-4e12-a7a7-667eafac42a5

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250159Gris-PEGNDARemedyrepack Inc.2013-02-22GRISEOFULVINORALTABLET, FILM COATED008840773NDA050475dd1f892c-de6a-4944-833b-a24ada1124e4
2538080261Gris-PEGNDAState Of Florida Doh Central Pharmacy2009-07-01GRISEOFULVINORALTABLET, FILM COATED008840773NDA0504759ddd37f9-299e-4c98-91ed-deeb72c63b00

griseofulvin 500 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007815515ANDASandoz Inc2013-08-07GRISEOFULVINORALTABLETANDA09159298829d90-b289-4bec-a625-7af412a5cb2d
2649800186ANDARising Pharmaceuticals, Inc.2012-10-23GRISEOFULVINORALTABLETANDA2024826149c044-58bb-402c-a4b5-18b96dd9b3b9

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA062279GRIFULVIN VVALEANT PHARMACEUTICALS LUXEMBOURG SARLANDA062279_001, ANDA062279_002, ANDA062279_003
2ANDA091592GRISEOFULVINSANDOZ INC2013-08-07ANDA091592_001, ANDA091592_002
3ANDA202482GRISEOFULVINSIGMAPHARM LABORATORIES LLC2012-10-22ANDA202482_001
4ANDA202545GRISEOFULVIN,ULTRAMICROSIZESIGMAPHARM LABORATORIES LLC2012-10-22ANDA202545_001, ANDA202545_002
5ANDA204371GRISEOFULVIN, ULTRAMICROSIZERICONPHARMA LLC2014-01-09ANDA204371_001, ANDA204371_002
6NDA050475GRIS-PEGVALEANT PHARMACEUTICALS INTERNATIONAL INCNDA050475_001, NDA050475_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA062279_001discontinuedGRISEOFULVIN, MICROCRYSTALLINE (125MG)ORALTABLETFalseGRIFULVIN V
2ANDA062279_002discontinuedGRISEOFULVIN, MICROCRYSTALLINE (250MG)ORALTABLETFalseGRIFULVIN V
3ANDA062279_003RXGRISEOFULVIN, MICROSIZE (500MG)ORALTABLETTrueABGRIFULVIN V
4ANDA091592_001RXGRISEOFULVIN, MICROSIZE (250MG)ORALTABLETFalse2013-08-07GRISEOFULVIN
5ANDA091592_002RXGRISEOFULVIN, MICROSIZE (500MG)ORALTABLETFalseAB2013-08-07GRISEOFULVIN
6ANDA202482_001RXGRISEOFULVIN, MICROSIZE (500MG)ORALTABLETFalseAB2012-10-22GRISEOFULVIN
7ANDA202545_001RXGRISEOFULVIN, ULTRAMICROSIZE (125MG)ORALTABLETFalseAB2012-10-22GRISEOFULVIN,ULTRAMICROSIZE
8ANDA202545_002RXGRISEOFULVIN, ULTRAMICROSIZE (250MG)ORALTABLETFalseAB2012-10-22GRISEOFULVIN,ULTRAMICROSIZE
9ANDA204371_001RXGRISEOFULVIN, ULTRAMICROSIZE (125MG)ORALTABLETFalseAB2014-01-09GRISEOFULVIN, ULTRAMICROSIZE
10ANDA204371_002RXGRISEOFULVIN, ULTRAMICROSIZE (250MG)ORALTABLETFalseAB2014-01-09GRISEOFULVIN, ULTRAMICROSIZE
11NDA050475_001RXGRISEOFULVIN, ULTRAMICROSIZE (125MG)ORALTABLETFalseABGRIS-PEG
12NDA050475_002RXGRISEOFULVIN, ULTRAMICROSIZE (250MG)ORALTABLETTrueABGRIS-PEG

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
120aa6571-ee10-4dc1-9be9-018aa0a680fc (view SPL)Gris-PEG (griseofulvin ultramicrosize)Tablets, USP125 mg; 250 mgprescriptionHuman PrescriptionPedinol Pharmacal Inc.manufacture2010-10-134008840763, 008840773
239ac6363-93bc-4e12-a7a7-667eafac42a5 (view SPL)Griseofulvin Ultramicrosize Tablets, USPprescriptionHuman PrescriptionOceanside PharmaceuticalsMANUFACTURE2015-04-132686820519, 686820520
36149c044-58bb-402c-a4b5-18b96dd9b3b9 (view SPL)GRISEOFULVIN TABLETS, USP (MICROSIZE) Rx OnlyprescriptionHuman PrescriptionRising Pharmaceuticals, Inc.API/FDF ANALYTICAL TESTING, manufacture, pack2012-11-023649800186
498829d90-b289-4bec-a625-7af412a5cb2d (view SPL)Griseofulvin Tablets, USP (MICROSIZE) 250 mg and 500 mgprescriptionHuman PrescriptionSandoz Inc2013-08-081007815514, 007815515
5993f0609-0f63-4bd5-b383-a19a00945c7e (view SPL)Ultramicrosize Griseofulvin Tablets, USPprescriptionHuman PrescriptionRiconpharma Llc.manufacture2014-01-247511250005, 511250006
69ddd37f9-299e-4c98-91ed-deeb72c63b00 (view SPL)Gris-PEG (griseofulvin ultramicrosize)Tablets, USP125 mg; 250 mgprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-06-011538080261
7db32d4ad-28a0-4f3e-ac7b-d8c6ec72d146 (view SPL)Ultramicrosize Griseofulvin Tablets, USPprescriptionHuman PrescriptionCorepharma, Llcmanufacture2014-09-3011647200295, 647200296
8dd1f892c-de6a-4944-833b-a24ada1124e4 (view SPL)Gris-PEG(griseofulvin ultramicrosize)Tablets, USP125 mg; 250 mgprescriptionHuman PrescriptionRemedyrepack Inc.2013-02-222521250159
9f3c468b7-9412-4f49-a7e2-9400b42c7c68 (view SPL)ULTRAMICROSIZE GRISEOFULVIN TABLETS, USP Rx OnlyprescriptionHuman PrescriptionRising Pharmaceuticals, Inc.API/FDF ANALYTICAL TESTING, manufacture, pack2012-11-024649800184, 649800185

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