Application 077701

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIPROFLOXACIN EXTENDED RELEASECIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL425.2MG;EQ 574.9MG BASENoNo
002CIPROFLOXACIN EXTENDED RELEASECIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL212.6MG;EQ 287.5MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55111-423Ciprofloxacinciprofloxacin hydrochlorideDr. Reddy's Laboratories LimitedANDACurrent