FDA.report

Application 075185

Type
ANDA
Sponsor
CARLSBAD

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUMDICLOFENAC SODIUMTABLET, DELAYED RELEASE;ORAL75MGNoNo
002DICLOFENAC SODIUMDICLOFENAC SODIUMTABLET, DELAYED RELEASE;ORAL25MGNoNo
003DICLOFENAC SODIUMDICLOFENAC SODIUMTABLET, DELAYED RELEASE;ORAL50MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-6396Diclofenac SodiumDiclofenac SodiumLiberty Pharmaceuticals, Inc.ANDACurrent
10544-188Diclofenac SodiumDiclofenac SodiumBlenheim Pharmacal, Inc.ANDACurrent
10544-189Diclofenac SodiumDiclofenac SodiumBlenheim Pharmacal, Inc.ANDACurrent
42254-059Diclofenac SodiumDiclofenac SodiumRebel Distributors CorpANDACurrent
42291-230Diclofenac SodiumDiclofenac SodiumAvKARE, Inc.ANDACurrent
42291-230Diclofenac SodiumDiclofenac SodiumAvKAREANDACurrent
42291-231Diclofenac SodiumDiclofenac SodiumAvKARE, Inc.ANDACurrent
42291-231Diclofenac SodiumDiclofenac SodiumAvKAREANDACurrent
43063-693Diclofenac SodiumDiclofenac SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-694Diclofenac SodiumDiclofenac SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-784Diclofenac SodiumDiclofenac SodiumAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
45865-999Diclofenac SodiumDiclofenac Sodiummedsource pharmaceuticalsANDACurrent
50090-0542Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
50090-0542Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
50090-0542Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
50090-0542Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
50090-0542Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
50090-0543Diclofenac Sodium Delayed ReleaseDiclofenac SodiumA-S Medication SolutionsANDACurrent
50090-0543Diclofenac Sodium Delayed ReleaseDiclofenac SodiumA-S Medication SolutionsANDACurrent
50090-0545Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
50090-0545Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
50090-0545Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
50090-0545Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
50090-0545Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
50090-0545Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
50436-1003Diclofenac SodiumDiclofenac SodiumUnit Dose ServicesANDACurrent
50436-1022Diclofenac SodiumDiclofenac SodiumUnit Dose ServicesANDACurrent
51655-176Diclofenac SodiumDiclofenac SodiumNORTHWIND PHARMACEUTICALSANDACurrent
53002-5360Diclofenac SodiumDiclofenac SodiumRPK Pharmaceuticals, Inc.ANDACurrent
53002-5360Diclofenac SodiumDiclofenac SodiumRPK Pharmaceuticals, Inc.ANDACurrent
53002-5370Diclofenac SodiumDiclofenac SodiumRPK Pharmaceuticals, Inc.ANDACurrent
53002-5370Diclofenac SodiumDiclofenac SodiumRPK Pharmaceuticals, Inc.ANDACurrent
55700-834Diclofenac SodiumDiclofenac SodiumQuality Care Products, LLCANDACurrent
55700-834Diclofenac SodiumDiclofenac SodiumQuality Care Products, LLCANDACurrent
55700-834Diclofenac SodiumDiclofenac SodiumQuality Care Products, LLCANDACurrent
59088-093Inflammacindiclofenac sodium, capsaicinPureTek CorporationANDACurrent
59088-093Inflammacindiclofenac sodium, capsaicinPureTek CorporationANDACurrent
60760-153Diclofenac SodiumDiclofenac SodiumSt. Mary's Medical Park PharmacyANDACurrent
60760-154Diclofenac SodiumDiclofenac SodiumSt. Mary's Medical Park PharmacyANDACurrent
60760-154Diclofenac SodiumDiclofenac SodiumSt. Mary's Medical Park PharmacyANDACurrent
61145-101Diclofenac SodiumDiclofenac SodiumRePharm PharmaceuticalsANDACurrent
61145-101Diclofenac SodiumDiclofenac SodiumRePharm PharmaceuticalsANDACurrent
61145-101Diclofenac SodiumDiclofenac SodiumREPHARM LLCANDACurrent
61145-102Diclofenac SodiumDiclofenac SodiumRePharm PharmaceuticalsANDACurrent
61145-102Diclofenac SodiumDiclofenac SodiumRePharm PharmaceuticalsANDACurrent
61145-102Diclofenac SodiumDiclofenac SodiumREPHARM LLCANDACurrent
61442-101Diclofenac SodiumDiclofenac SodiumCarlsbad Technology, Inc.ANDACurrent
61442-102Diclofenac SodiumDiclofenac SodiumCarlsbad Technology, Inc.ANDACurrent
61442-103Diclofenac SodiumDiclofenac SodiumCarlsbad Technology, Inc.ANDACurrent
61919-074Diclofenac Sodium D/RDiclofenac Sodium D/RDirect RXANDACurrent
61919-074Diclofenac Sodium D/RDiclofenac Sodium D/RDirect RXANDACurrent
61919-074Diclofenac Sodium D/RDiclofenac Sodium D/RDirect RXANDACurrent
61919-075Diclofenac Sodium D/RDiclofenac Sodium D/RDirect RXANDACurrent
61919-075Diclofenac Sodium D/RDiclofenac Sodium D/RDirect_RxANDACurrent
61919-075Diclofenac Sodium D/RDiclofenac Sodium D/RDirect_RxANDACurrent
61919-075Diclofenac Sodium D/RDiclofenac Sodium D/RDirect RXANDACurrent
61919-075Diclofenac Sodium D/RDiclofenac Sodium D/RDirect RXANDACurrent
63187-222Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
63187-222Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
63629-1011Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
63629-1011Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
63629-1011Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
63629-1012Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
63629-1012Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
63629-1012Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
63629-1534Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
63629-2010Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
63629-2010Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
63629-2011Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
63629-2011Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
63629-2012Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
63629-2012Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
63629-2013Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
63629-2013Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
63629-2077Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
63629-2077Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
63629-7654Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
63629-7654Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
63629-7655Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent
63629-7655Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackANDACurrent

Documents

DocumentTitleSubmission typeSubmission no.Date
85550ORIG11998-11-13