Application 065436

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET;ORALEQ 50MG BASENoNo
002MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET;ORALEQ 75MG BASENoNo
003MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET;ORALEQ 100MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55111-637Minocycline HydrochlorideMinocycline HydrochlorideDr. Reddy's Laboratories LimitedANDACurrent
55111-637Minocycline HydrochlorideMinocycline HydrochlorideDr. Reddy's Laboratories LimitedANDACurrent
55111-638Minocycline HydrochlorideMinocycline HydrochlorideDr. Reddy's Laboratories LimitedANDACurrent
55111-638Minocycline HydrochlorideMinocycline HydrochlorideDr. Reddy's Laboratories LimitedANDACurrent
55111-639Minocycline HydrochlorideMinocycline HydrochlorideDr. Reddy's Laboratories LimitedANDACurrent
55111-639Minocycline HydrochlorideMinocycline HydrochlorideDr. Reddy's Laboratories LimitedANDACurrent
70518-0359Minocycline HydrochlorideMinocycline HydrochlorideREMEDYREPACK INC.ANDACurrent