Application 202409

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLINDAMYCIN PALMITATE HYDROCHLORIDECLINDAMYCIN PALMITATE HYDROCHLORIDEFOR SOLUTION;ORALEQ 75MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-483Clindamycin Palmitate Hydrochloride (Pediatric)Clindamycin Palmitate Hydrochloride (Pediatric)NorthStar Rx LLCANDACurrent
16714-483Clindamycin Palmitate Hydrochloride (Pediatric)Clindamycin Palmitate Hydrochloride (Pediatric)NorthStar Rx LLCANDACurrent
16714-483Clindamycin Palmitate Hydrochloride (Pediatric)Clindamycin Palmitate Hydrochloride (Pediatric)NorthStar Rx LLCANDACurrent
16714-483Clindamycin Palmitate Hydrochloride (Pediatric)Clindamycin Palmitate Hydrochloride (Pediatric)NorthStar Rx LLCANDACurrent
16714-483Clindamycin Palmitate Hydrochloride (Pediatric)Clindamycin Palmitate Hydrochloride (Pediatric)NorthStar Rx LLCANDACurrent
65862-596Clindamycin Palmitate Hydrochloride (Pediatric)Clindamycin Palmitate Hydrochloride (Pediatric)Aurobindo Pharma LimitedANDACurrent
65862-596Clindamycin Palmitate Hydrochloride (Pediatric)Clindamycin Palmitate Hydrochloride (Pediatric)Aurobindo Pharma LimitedANDACurrent
65862-596Clindamycin Palmitate Hydrochloride (Pediatric)Clindamycin Palmitate Hydrochloride (Pediatric)Aurobindo Pharma LimitedANDACurrent
65862-596Clindamycin Palmitate Hydrochloride (Pediatric)Clindamycin Palmitate Hydrochloride (Pediatric)Aurobindo Pharma LimitedANDACurrent
65862-596Clindamycin Palmitate Hydrochloride (Pediatric)Clindamycin Palmitate Hydrochloride (Pediatric)Aurobindo Pharma LimitedANDACurrent
65862-596Clindamycin Palmitate Hydrochloride (Pediatric)Clindamycin Palmitate Hydrochloride (Pediatric)Aurobindo Pharma LimitedANDACurrent