Application 020612

Type
NDA
Sponsor
TEIKOKU PHARMA USA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001LIDODERMLIDOCAINEPATCH;TOPICAL5%YesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-1880LidocainelidocainePar PharmaceuticalNDA AUTHORIZED GENERICCurrent
49999-419LIDODERMlidocaineLake Erie Medical DBA Quality Care Products LLCNDACurrent
50090-1359LidocainelidocaineA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50436-1331LIDODERMlidocaineUnit Dose ServicesNDACurrent
55154-7228LidocainelidocaineCardinal HealthNDA AUTHORIZED GENERICCurrent
55154-7228LidocainelidocaineCardinal HealthNDA AUTHORIZED GENERICCurrent
55154-7228LidocainelidocaineCardinal Health 107, LLCNDA AUTHORIZED GENERICCurrent
55700-142LidocainelidocaineLake Erie Medical DBA QuaNDA AUTHORIZED Current
55700-142LidocainelidocaineLake Erie Medical DBA Quality Care Products LLCNDA AUTHORIZED GENERICCurrent
60760-880LidocainelidocaineSt. Mary's Medical Park PharmacyNDA AUTHORIZED GENERICCurrent
61919-588LIDOCAINELIDOCAINEDIRECT RXNDA AUTHORIZED GENERICCurrent
61959-001LIDODERMLidocaine Patch 5%TPU Pharma, Inc.NDACurrent
63481-687LIDODERMlidocaineEndo Pharmaceuticals, Inc.NDACurrent
63481-687LIDODERMlidocaineEndo Pharmaceuticals Inc.NDACurrent
63481-687LIDODERMlidocaineEndo Pharmaceuticals, Inc.NDACurrent
68071-2460LidocainelidocaineNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68788-7159LidocainelidocainePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7159LidocainelidocainePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7159LidocainelidocainePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7159LidocainelidocainePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
71335-1934LidocainelidocaineBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
76519-1044LIDOCAINELIDOCAINEH.J. Harkins Company, Inc.NDA AUTHORIZED GENERICCurrent

Documents

DocumentSubmission typeDate
56357SUPPL2018-11-08
56265SUPPL2018-11-05
12848SUPPL2015-01-08
2879SUPPL2015-01-08
34958SUPPL2010-04-19
2878SUPPL2010-04-19
41480SUPPL2006-10-26
20767SUPPL2006-10-26
12847SUPPL2006-05-01
2877SUPPL2006-05-01
34957SUPPL2005-05-17
2876SUPPL2005-05-17
20766ORIG1999-06-17
34956ORIG1999-03-19
2875ORIG1999-03-19