FDA.reportPublic FDA data

Application 202769

Type
ANDA
Sponsor
TELIGENT PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUMDICLOFENAC SODIUMSOLUTION;TOPICAL1.5%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45865-964Diclofenac SodiumDiclofenac Sodiummedsource pharmaceuticalsANDACurrent
50090-4018Diclofenac Sodiumdiclofenac sodiumA-S Medication SolutionsANDACurrent
50436-2225Diclofenac Sodium 1.5%Diclofenac Sodium TopicalUnit Dose ServicesANDACurrent
51021-150Diclofenac SodiumDiclofenac SodiumSircle Laboratories, LLCANDACurrent
52565-002Diclofenac Sodiumdiclofenac sodiumTeligent Pharma, Inc.ANDACurrent
52565-002Diclofenac Sodiumdiclofenac sodiumTeligent Pharma, Inc.ANDACurrent
55700-591Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-591Diclofenac SodiumDiclofenac SodiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-591Diclofenac SodiumDiclofenac SodiumQuality Care Products LLCANDACurrent
55700-878Diclofenac Sodium 1.5%Diclofenac Sodium Topical SolutionQuality Care Products, LLCANDACurrent
59088-343DermacinRx Lexitral PharmaPakdiclofenac sodium, capsaicinPureTek CorporationANDACurrent
59088-343DermacinRx Lexitral PharmaPakdiclofenac sodium, capsaicinPureTek CorporationANDACurrent
59088-365XrylixDiclofenac SodiumPureTek CorporationANDACurrent
59088-365XrylixDiclofenac SodiumPureTek CorporationANDACurrent
59088-372Diclofenac SodiumDiclofenac SodiumPureTek CorporationANDACurrent
59088-372Diclofenac SodiumDiclofenac SodiumPureTek CorporationANDACurrent
59088-372Diclofenac SodiumDiclofenac SodiumPureTek CorporationANDACurrent
59088-372Diclofenac SodiumDiclofenac SodiumPureTek CorporationANDACurrent
59088-372Diclofenac SodiumDiclofenac SodiumPureTek CorporationANDACurrent
59088-704Leximenthdiclofenac sodium, lidocaine, mentholPureTek CorporationANDACurrent
59088-704Leximenthdiclofenac sodium, lidocaine, mentholPureTek CorporationANDACurrent
59088-716Diclotrexdiclofenac sodium, camphor, mentholPureTek CorporationANDACurrent
59088-716Diclotrexdiclofenac sodium, camphor, mentholPureTek CorporationANDACurrent
60760-112Diclofenac SodiumDiclofenac SodiumSt. Mary's Medical Park PharmacyANDACurrent
61919-675DICLOFENAC SODIUMDICLOFENAC SODIUMDIRECT RXANDACurrent
61919-675DICLOFENAC SODIUMDICLOFENAC SODIUMDIRECT RXANDACurrent
63187-677Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
68788-6368Diclofenac SodiumDiclofenac SodiumPreferred Pharmcacuticals Inc.ANDACurrent
68788-7701Diclofenac Sodium 1.5%Diclofenac Sodium Topical SolutionPreferred Pharmaceuticals Inc.ANDACurrent
68788-7701Diclofenac Sodium 1.5%Diclofenac Sodium Topical SolutionPreferred Pharmaceuticals Inc.ANDACurrent
69621-343Xelitraldiclofenac sodium, capsaicinShoreline PharmaceuticalsANDACurrent
69621-365LexixrylDiclofenac SodiumShoreline Pharmaceuticals, Inc.ANDACurrent
69621-707TriXylitralDiclofenac Sodium, Lidocaine HydrochlorideShoreline PharmaceuticalsANDACurrent
70512-025Diclofenac Sodium 1.5%Diclofenac Sodium Topical SolutionKBS Solutions LLCANDACurrent
70512-025Diclofenac Sodium 1.5%Diclofenac Sodium Topical SolutionKBS Solutions LLCANDACurrent
70512-025Diclofenac Sodium 1.5%Diclofenac Sodium Topical SolutionSOLA PharmaceuticalsANDACurrent
70512-025Diclofenac Sodium 1.5%Diclofenac Sodium Topical SolutionKBS Solutions LLCANDACurrent
70512-025Diclofenac Sodium 1.5%Diclofenac Sodium Topical SolutionSola PharmaceuticalsANDACurrent
70518-2944Diclofenac Sodiumdiclofenac sodiumREMEDYREPACK INC.ANDACurrent
70518-2944Diclofenac Sodiumdiclofenac sodiumREMEDYREPACK INC.ANDACurrent
70518-2944Diclofenac Sodiumdiclofenac sodiumREMEDYREPACK INC.ANDACurrent
70518-2944Diclofenac Sodiumdiclofenac sodiumREMEDYREPACK INC.ANDACurrent
70859-003NuDiclo SoluPakdiclofenac sodium, capsaicinNucare Pharmaceuticals IncANDACurrent
70859-003NuDiclo SoluPakdiclofenac sodium, capsaicinNucare Pharmaceuticals IncANDACurrent
70859-003NuDiclo SoluPakdiclofenac sodium, capsaicinNucare Pharmaceuticals IncANDACurrent
70859-045DFS 1.5%/MS 25%/MENTH 6%/CAP 0.025% PAKdiclofenac sodium, Methyl Salicylate/Menthol/CapsaicinNucare Pharmaceuticals IncANDACurrent
70859-045DFS 1.5%/MS 25%/MENTH 6%/CAP 0.025% PAKdiclofenac sodium, Methyl Salicylate/Menthol/CapsaicinNucare Pharmaceuticals IncANDACurrent
71205-138Diclofenac Sodium 1.5%Diclofenac Sodium Topical SolutionProficient Rx LPANDACurrent
71205-138Diclofenac Sodium 1.5%Diclofenac Sodium Topical SolutionProficient Rx LPANDACurrent
71205-138Diclofenac Sodium 1.5%Diclofenac Sodium Topical SolutionProficient Rx LPANDACurrent
71205-450Diclofenac Sodiumdiclofenac sodiumProficient Rx LPANDACurrent
72275-702Diclovixdiclofenac sodium, with camphor, lidocaine, and methyl salicylate patchPrimary Pharmaceuticals, IncANDACurrent
72275-719Diclovix Mdiclofenac sodium, with camphor, lidocaine, and methyl salicylate patchPrimary Pharmaceuticals, IncANDACurrent
72275-734Diclovix CMdiclofenac sodium, with capsaicin cream and camphor, lidocaine, and methyl salicylate patchPrimary Pharmaceuticals, IncANDACurrent
72275-746PennsaicinDiclofenac Sodium Topical with Capsaicin CreamPrimary Pharmaceuticals, IncANDACurrent
72275-746PennsaicinDiclofenac Sodium Topical with Capsaicin CreamPrimary Pharmaceuticals, IncANDACurrent
81877-502DicloHeal-60diclofenac sodium, capsaicinForreal Pharmaceuticals LLCANDACurrent
81877-502DicloHeal-60diclofenac sodium, capsaicinForreal Pharmaceuticals LLCANDACurrent
81877-502DicloHeal-60diclofenac sodium, capsaicinForreal Pharmaceuticals LLCANDACurrent