Diclofenac Oral Capsule

Brand(s)
Zipsor, Zorvolex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Depomed, Inc. (2015-09-01)
Oldest Current Product
2009-06-16
License(s)
NDA
RxNORM
ORAL CAPSULE\DICLOFENAC
FDAOB
ORAL\CAPSULE\DICLOFENAC
ORAL\CAPSULE\DICLOFENAC POTASSIUM
SPL Active
ORAL\CAPSULE, LIQUID FILLED\DICLOFENAC POTASSIUM
ORAL\CAPSULE\DICLOFENAC
SPL Moiety
ORAL\CAPSULE, LIQUID FILLED\DICLOFENAC
ORAL\CAPSULE\DICLOFENAC

product(s) by strength(s)

diclofenac 18 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1422110203ZorvolexNDAIroko Pharmaceuticals, Llc2013-10-31DICLOFENACORALCAPSULENDA204592dff10e66-a577-451d-ba75-1889458ca833

diclofenac 35 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1422110204ZorvolexNDAIroko Pharmaceuticals, Llc2013-10-31DICLOFENACORALCAPSULENDA204592dff10e66-a577-451d-ba75-1889458ca833

diclofenac potassium 25 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1139130008ZipsorNDADepomed, Inc.2009-06-16DICLOFENAC POTASSIUMORALCAPSULE, LIQUID FILLEDNDA022202c982eca0-fc41-11e1-a9c8-0002a5d5c51b

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560537ZipsorNDALake Erie Medical Dba Quality Care Products Llc2010-12-22DICLOFENAC POTASSIUMORALCAPSULE, LIQUID FILLED664790592NDA02220261420046-b04b-4532-a21d-65986966f681
2430630205ZipsorNDAPd-Rx Pharmaceuticals, Inc.2010-04-30DICLOFENAC POTASSIUMORALCAPSULE, LIQUID FILLED664790592NDA022202b20c6938-cf96-4175-9eb3-d6ae3a43059c

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022202ZIPSORDEPOMED INC2009-06-16p6287594, SUBSTANCE
p7884095, NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
p7662858, NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
p8623920, DICLOFENAC POTASSIUM FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
p8110606, NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
p6365180, NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN, SUBSTANCE
p7939518, NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
NDA022202_001
2NDA204592ZORVOLEXIROKO PHARMACEUTICALS LLC2013-10-18p9173854, SUBSTANCE
p9180096, SUBSTANCE
p8999387, TREATMENT OF PAIN
p9017721, SUBSTANCE
p8679544, SUBSTANCE
INDICATED FOR MANAGEMENT OF OSTEOARTHRITIS PAIN. [2017-08-22]
NEW PRODUCT [2016-10-18]
NDA204592_001, NDA204592_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022202_001RXDICLOFENAC POTASSIUM (25MG)ORALCAPSULETrue2009-06-16ZIPSOR
2NDA204592_001RXDICLOFENAC (18MG)ORALCAPSULEFalse2013-10-18ZORVOLEX
3NDA204592_002RXDICLOFENAC (35MG)ORALCAPSULETrue2013-10-18ZORVOLEX

patent(s)

#idexpiration dateapplication(s)
1p6287594 (view patent)2019-01-15NDA022202
2p6365180 (view patent)2019-07-15NDA022202
3p7662858 (view patent)2029-02-24NDA022202
4p7884095 (view patent)2029-02-24NDA022202
5p7939518 (view patent)2029-02-24NDA022202
6p8110606 (view patent)2029-02-24NDA022202
7p8623920 (view patent)2029-02-24NDA022202
8p8679544 (view patent)2030-04-23NDA204592
9p8999387 (view patent)2030-04-23NDA204592
10p9017721 (view patent)2030-04-23NDA204592
11p9173854 (view patent)2030-04-23NDA204592
12p9180096 (view patent)2030-04-23NDA204592

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
161420046-b04b-4532-a21d-65986966f681 (view SPL)These highlights do not include all the information needed to use Zipsor safely and effectively. See full prescribing information for Zipsor. Zipsor (diclofenac potassium) Liquid Filled CapsuleInitial U.S. Approval: [1988]prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products LlcMANUFACTURE, repack2010-12-222043353560537
2b20c6938-cf96-4175-9eb3-d6ae3a43059c (view SPL)These highlights do not include all the information needed to use Zipsor safely and effectively. See full prescribing information for Zipsor. Zipsor (diclofenac potassium) Liquid Filled CapsuleInitial U.S. Approval: [1988]prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2009-06-056430630205
3c982eca0-fc41-11e1-a9c8-0002a5d5c51b (view SPL)These highlights do not include all the information needed to use Zipsor safely and effectively. See full prescribing information for Zipsor. Zipsor (diclofenac potassium) Liquid Filled CapsuleInitial U.S. Approval: [1988]prescriptionHuman PrescriptionDepomed, Inc.LABEL, MANUFACTURE, PACK2015-09-017139130008
4dff10e66-a577-451d-ba75-1889458ca833 (view SPL)These highlights do not include all the information needed to use ZORVOLEX safely and effectively. See full prescribing information for ZORVOLEX. ZORVOLEX (diclofenac) capsules, for oral useInitial U.S. Approval: 1988prescriptionHuman PrescriptionIroko Pharmaceuticals, Llcmanufacture2014-08-294422110203, 422110204

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