FDA.reportPublic FDA data

Application 203037

Type
ANDA
Sponsor
UNIMARK REMEDIES LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MONTELUKAST SODIUMMONTELUKAST SODIUMTABLET, CHEWABLE;ORALEQ 4MG BASENoNo
002MONTELUKAST SODIUMMONTELUKAST SODIUMTABLET, CHEWABLE;ORALEQ 5MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9650MONTELUKASTMONTELUKASTWest ward Pharmaceutical CorpANDACurrent
0143-9651MONTELUKASTMONTELUKASTWest ward Pharmaceutical CorpANDACurrent
51128-502MONTELUKASTMONTELUKASTRecipharm Pharmaservices Private LimitedANDACurrent
51128-502MONTELUKASTMONTELUKASTRecipharm Pharmaservices Private LimitedANDACurrent
51128-503MONTELUKASTMONTELUKASTRecipharm Pharmaservices Private LimitedANDACurrent
51128-503MONTELUKASTMONTELUKASTRecipharm Pharmaservices Private LimitedANDACurrent
63187-626MONTELUKASTMONTELUKASTProficient Rx LPANDACurrent
63187-626MONTELUKASTMONTELUKASTProficient Rx LPANDACurrent
68788-7387MONTELUKASTMONTELUKASTPreferred Pharmaceuticals Inc.ANDACurrent
68788-7387MONTELUKASTMONTELUKASTPreferred Pharmaceuticals Inc.ANDACurrent
69452-106MONTELUKASTMONTELUKASTBionpharma Inc.ANDACurrent
69452-106MONTELUKASTMONTELUKASTBionpharma Inc.ANDACurrent
69452-106MONTELUKASTMONTELUKASTBionpharma Inc.ANDACurrent
69452-107MONTELUKASTMONTELUKASTBionpharma Inc.ANDACurrent
69452-107MONTELUKASTMONTELUKASTBionpharma Inc.ANDACurrent
69452-107MONTELUKASTMONTELUKASTBionpharma Inc.ANDACurrent