FDA.reportPublic FDA data

Application 205318

Type
ANDA
Sponsor
TELIGENT PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINELIDOCAINEOINTMENT;TOPICAL5%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0028Lidocaine 5%Lidocaine 5% creamATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0028Lidocaine 5%Lidocaine 5% creamATLANTIC BIOLOGICALS CORP.ANDACurrent
50383-341LidocainelidocaineHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-341LidocainelidocaineAkornANDACurrent
52565-008LidocainelidocaineTeligent Pharma, Inc.ANDACurrent
53217-248LidocainelidocaineAidarex Pharmaceuticals LLCANDACurrent
55700-464LidocainelidocaineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-464LidocainelidocaineLake Erie Medical DBA Quality Care Products LLCANDACurrent
59088-811DermacinRx Lido V PakLidocainePureTek CorporationANDACurrent
59088-811DermacinRx Lido V PakLidocainePureTek CorporationANDACurrent
61919-774LIDOCAINELIDOCAINEDIRECTRXANDACurrent
61919-774LIDOCAINELIDOCAINEDIRECTRXANDACurrent
68071-4628LidocainelidocaineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4628LidocainelidocaineNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6430LidocainelidocainePreferred Pharmaceuticals Inc.ANDACurrent
68788-7486Lidocaine 5%Lidocaine 5% creamPreferred Pharmaceuticals Inc.ANDACurrent
68788-7486Lidocaine 5%Lidocaine 5% creamPreferred Pharmaceuticals Inc.ANDACurrent
68788-7486Lidocaine 5%Lidocaine 5% creamPreferred Pharmaceuticals Inc.ANDACurrent
69621-821Zeyocainelidocaine, isopropyl alcoholShoreline Pharmaceuticals, Inc.ANDACurrent
70512-027Lidocaine 5%Lidocaine 5% creamKBS Solutions, LLCANDACurrent
70512-027Lidocaine 5%Lidocaine 5% creamKBS Solutions, LLCANDACurrent
70512-027Lidocaine 5%Lidocaine 5% creamSOLA PharmaceuticalsANDACurrent
70512-027Lidocaine 5%Lidocaine 5% creamSOLA PharmaceuticalsANDACurrent
70518-2355LidocainelidocaineREMEDYREPACK INC.ANDACurrent
70518-2355LidocainelidocaineREMEDYREPACK INC.ANDACurrent
70518-2355LidocainelidocaineREMEDYREPACK INC.ANDACurrent
70518-2355LidocainelidocaineREMEDYREPACK INC.ANDACurrent
71205-342LidocainelidocaineProficient Rx LPANDACurrent
72275-716Lidovix LLidocaine 5%Primary Pharmaceuticals, Inc.ANDACurrent
72275-716Lidovix LLidocaine 5%Primary Pharmaceuticals, Inc.ANDACurrent
73272-300LidoStreamLidocaine 5% Ointment and Menthol 10% Topical LiquidUpstream Pharma, LLCANDACurrent
76420-131LidocainelidocaineAsclemed USA, Inc.ANDACurrent
80175-0008lidocainelidocaineCentral PackagingANDACurrent
80175-0008lidocainelidocaineCentral PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10435ORIG2016-02-03