FDA.reportPublic FDA data

Application 065425

Type
ANDA
Sponsor
AMNEAL PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEMECLOCYCLINE HYDROCHLORIDEDEMECLOCYCLINE HYDROCHLORIDETABLET;ORAL150MGNoNo
002DEMECLOCYCLINE HYDROCHLORIDEDEMECLOCYCLINE HYDROCHLORIDETABLET;ORAL300MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6180Demeclocycline HydrochlorideDemeclocyclineMajor PharmaceuticalsANDACurrent
0904-6180Demeclocycline HydrochlorideDemeclocyclineMajor PharmaceuticalsANDACurrent
0904-6649Demeclocycline HydrochlorideDemeclocyclineMajor PharmaceuticalsANDACurrent
0904-6649Demeclocycline HydrochlorideDemeclocyclineMajor PharmaceuticalsANDACurrent
42291-264Demeclocycline HydrochlorideDemeclocyclineAvKARE, Inc.ANDACurrent
42291-265Demeclocycline HydrochlorideDemeclocyclineAvKARE, Inc.ANDACurrent
42291-265Demeclocycline HydrochlorideDemeclocyclineAvKARE, Inc.ANDACurrent
53746-554Demeclocycline HydrochlorideDemeclocyclineAmneal Pharmaceuticals of New York LLCANDACurrent
53746-554Demeclocycline HydrochlorideDemeclocyclineAmneal Pharmaceuticals of New York LLCANDACurrent
53746-555Demeclocycline HydrochlorideDemeclocyclineAmneal Pharmaceuticals of New York LLCANDACurrent
53746-555Demeclocycline HydrochlorideDemeclocyclineAmneal Pharmaceuticals of New York LLCANDACurrent
60687-691Demeclocycline HydrochlorideDemeclocyclineAmerican Health PackagingANDACurrent
60687-691Demeclocycline HydrochlorideDemeclocyclineAmerican Health PackagingANDACurrent
60687-705Demeclocycline HydrochlorideDemeclocyclineAmerican Health PackagingANDACurrent
62584-159Demeclocycline HydrochlorideDemeclocycline HydrochlorideAmerican Health PackagingANDACurrent
62584-159Demeclocycline HydrochlorideDemeclocycline HydrochlorideAmerican Health PackagingANDACurrent
62584-159Demeclocycline HydrochlorideDemeclocycline HydrochlorideAmerican Health PackagingANDACurrent
62584-163Demeclocycline HydrochlorideDemeclocycline HydrochlorideAmerican Health PackagingANDACurrent
62584-163Demeclocycline HydrochlorideDemeclocycline HydrochlorideAmerican Health PackagingANDACurrent
62584-163Demeclocycline HydrochlorideDemeclocycline HydrochlorideAmerican Health PackagingANDACurrent
65162-554Demeclocycline HydrochlorideDemeclocyclineAmneal Pharmaceuticals LLCANDACurrent
65162-554Demeclocycline HydrochlorideDemeclocyclineAmneal Pharmaceuticals LLCANDACurrent
65162-554Demeclocycline HydrochlorideDemeclocyclineAmneal Pharmaceuticals LLCANDACurrent
65162-554Demeclocycline HydrochlorideDemeclocyclineAmneal Pharmaceuticals LLCANDACurrent
65162-555Demeclocycline HydrochlorideDemeclocyclineAmneal Pharmaceuticals LLCANDACurrent
65162-555Demeclocycline HydrochlorideDemeclocyclineAmneal Pharmaceuticals LLCANDACurrent
65162-555Demeclocycline HydrochlorideDemeclocyclineAmneal Pharmaceuticals LLCANDACurrent
65162-555Demeclocycline HydrochlorideDemeclocyclineAmneal Pharmaceuticals LLCANDACurrent
68151-0155Demeclocycline HydrochlorideDemeclocycline HydrochlorideCarilion Materials ManagementANDACurrent