FDA.reportPublic FDA data

Application 207810

Type
ANDA
Sponsor
ALKEM LABS LTD

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
0440-9715LidocaineLidocaineLiberty Pharmaceuticals, Inc.ANDACurrent
50436-0473LidocaineLidocaineUnit Dose ServicesANDACurrent
50436-0473LidocaineLidocaineUnit Dose ServicesANDACurrent
52959-993LIDOCAINELIDOCAINEH.J. Harkins Company, Inc.ANDACurrent
55700-681LidocaineLidocaineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-681LidocaineLidocaineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-681LidocaineLidocaineLake Erie Medical DBA QuaANDACurrent
55700-681LidocaineLidocaineLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-473LidocaineLidocaineSt. Mary's Medical Park PharmacyANDACurrent
63629-2503LidocaineLidocaineBryant Ranch PrepackANDACurrent
63629-2503LidocaineLidocaineBryant Ranch PrepackANDACurrent
63629-2504LidocaineLidocaineBryant Ranch PrepackANDACurrent
63629-2504LidocaineLidocaineBryant Ranch PrepackANDACurrent
63629-8848LidocaineLidocaineBryant Ranch PrepackANDACurrent
63629-8848LidocaineLidocaineBryant Ranch PrepackANDACurrent
63629-8848LidocaineLidocaineBryant Ranch PrepackANDACurrent
67877-473LidocaineLidocaineAscend Laboratories, LLCANDACurrent
67877-473LidocaineLidocaineAscend Laboratories, LLCANDACurrent
67877-473LidocaineLidocaineAscend Laboratories, LLCANDACurrent
70518-2147LidocaineLidocaineREMEDYREPACK INC.ANDACurrent
70518-2147LidocaineLidocaineREMEDYREPACK INC.ANDACurrent
70518-2147LidocaineLidocaineREMEDYREPACK INC.ANDACurrent
70518-2147LidocaineLidocaineREMEDYREPACK INC.ANDACurrent
71205-549LidocaineLidocaineProficient Rx LPANDACurrent
71205-549LidocaineLidocaineProficient Rx LPANDACurrent
71205-549LidocaineLidocaineProficient Rx LPANDACurrent
71205-549LidocaineLidocaineProficient Rx LPANDACurrent
71205-549LidocaineLidocaineProficient Rx LPANDACurrent
72189-168LIDOCAINELIDOCAINELIDOCAINEANDACurrent
72189-168LIDOCAINELIDOCAINELIDOCAINEANDACurrent
72189-168LIDOCAINELIDOCAINEDIRECT RXANDACurrent
72189-168LIDOCAINELIDOCAINEDIRECT RXANDACurrent