FDA.reportPublic FDA data

Application 210986

Type
ANDA
Sponsor
ENCUBE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUMDICLOFENAC SODIUMGEL;TOPICAL1%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-7065Diclofenac Sodium Topical Gel 1%diclofenac sodium topical gel, 1%Walgreens CompanyANDACurrent
0363-7065Diclofenac Sodium Topical Gel 1%diclofenac sodium topical gel, 1%Walgreens CompanyANDACurrent
0363-7065Diclofenac Sodium Topical Gel 1%diclofenac sodium topical gel, 1%Walgreens CompanyANDACurrent
21922-009Diclofenac SodiumDiclofenac Sodium Topical Gel, 1%,Encube Ethicals Private LimitedANDACurrent
21922-009Diclofenac SodiumDiclofenac Sodium Topical Gel, 1%,Encube Ethicals Private LimitedANDACurrent
21922-044DICLOFENAC SODIUMdiclofenac sodium topical gel, 1%Encube Ethicals Private LimitedANDACurrent
21922-044DICLOFENAC SODIUMdiclofenac sodium topical gel, 1%Encube Ethicals Private LimitedANDACurrent
21922-044Diclofenac Sodiumdiclofenac sodium topical gel, 1%Encube Ethicals Private LimitedANDACurrent
21922-044DICLOFENAC SODIUMdiclofenac sodium topical gel, 1%Encube Ethicals Private LimitedANDACurrent
30142-025Diclofenac Sodium Topical Gel 1%Diclofenac sodium topical gel, 1%Kroger CompanyANDACurrent
30142-025Diclofenac Sodium Topical Gel 1%Diclofenac sodium topical gel, 1%Kroger CompanyANDACurrent
30142-025Diclofenac Sodium Topical Gel 1%Diclofenac sodium topical gel, 1%Kroger CompanyANDACurrent
30142-025Diclofenac Sodium Topical Gel 1%Diclofenac sodium topical gel, 1%Kroger CompanyANDACurrent
43598-885DICLOFENAC SODIUMdiclofenac sodium topical gel, 1%Dr. Reddy's Laboratories Inc.ANDACurrent
43598-885DICLOFENAC SODIUMdiclofenac sodium topical gel, 1%Dr. Reddy's Laboratories Inc.ANDACurrent
43598-885DICLOFENAC SODIUMdiclofenac sodium topical gel, 1%Dr. Reddy's Laboratories Inc.ANDACurrent
43598-977DICLOFENAC SODIUMdiclofenac sodium topical gel, 1%Dr. Reddy's Laboratories Inc.ANDACurrent
43598-977DICLOFENAC SODIUMdiclofenac sodium topical gel, 1%Dr. Reddy's Laboratories Inc.ANDACurrent
43598-977DICLOFENAC SODIUMdiclofenac sodium topical gel, 1%Dr. Reddy's Laboratories Inc.ANDACurrent
53002-4642Diclofenac SodiumDiclofenac Sodium Topical Gel, 1%,RPK Pharmaceuticals, Inc.ANDACurrent
55700-863Diclofenac SodiumDiclofenac Sodium Topical Gel, 1%,Quality Care Products, LLCANDACurrent
57896-140DICLOFENAC SODIUMdiclofenac sodium topical gel, 1%GERI-CARE PHARMACEUTICALS CORPANDACurrent
63868-730DICLOFENAC SODIUMDiclofenac Sodium topical gel, 1%Chain Drug Marketing Association INCANDACurrent
68071-2239Diclofenac SodiumDiclofenac SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2239Diclofenac SodiumDiclofenac SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7772Diclofenac SodiumDiclofenac Sodium Topical Gel, 1%,Preferred Pharmaceuticals, Inc.ANDACurrent
68788-7772Diclofenac SodiumDiclofenac Sodium Topical Gel, 1%,Preferred Pharmaceuticals, Inc.ANDACurrent
68788-7772Diclofenac SodiumDiclofenac Sodium Topical Gel, 1%,Preferred Pharmaceuticals, Inc.ANDACurrent
70512-106Diclofenac SodiumDiclofenac Sodium 1%SOLA PharmaceuticalsANDACurrent
70512-106Diclofenac SodiumDiclofenac Sodium 1%SOLA PharmaceuticalsANDACurrent
70512-106Diclofenac SodiumDiclofenac Sodium 1%SOLA PharmaceuticalsANDACurrent
70518-2813Diclofenac SodiumDiclofenac Sodium Topical Gel, 1%,REMEDYREPACK INC.ANDACurrent
70518-2813Diclofenac SodiumDiclofenac Sodium Topical Gel, 1%,REMEDYREPACK INC.ANDACurrent
70518-2813Diclofenac SodiumDiclofenac Sodium Topical Gel, 1%,REMEDYREPACK INC.ANDACurrent
70518-2813Diclofenac SodiumDiclofenac Sodium Topical Gel, 1%,REMEDYREPACK INC.ANDACurrent
70677-0143Arthritis Paindiclofenac sodium topical gel, 1%Strategic Sourcing Services, LLCANDACurrent
71205-552Diclofenac SodiumDiclofenac Sodium Topical Gel, 1%,Proficient Rx LPANDACurrent
72559-020Curist Arthritis ReliefDiclofenac SodiumLittle Pharma, Inc.ANDACurrent
73715-005Diclofenac Sodium Topical Gel, 1%Diclofenac Sodium Topical Gel, 1% (NSAID)Mohnark Pharmaceuticals Inc.ANDACurrent
73715-005Diclofenac Sodium Topical Gel, 1%Diclofenac Sodium Topical Gel, 1% (NSAID)Mohnark Pharmaceuticals Inc.ANDACurrent
76420-091Diclofenac SodiumDiclofenac Sodium Topical Gel, 1%,Asclemed USA, Inc.ANDACurrent
82226-020ValcoPrep-100diclofenac sodium, isopropyl alcoholPlum Valley Pharma LLCANDACurrent
82226-020ValcoPrep-100diclofenac sodium, isopropyl alcoholPlum Valley Pharma LLCANDACurrent
82226-020ValcoPrep-100diclofenac sodium, isopropyl alcoholPlum Valley Pharma LLCANDACurrent