FDA.reportPublic FDA data

Application 209215

Type
ANDA
Sponsor
GUARDIAN DRUG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GUAIFENESINGUAIFENESINTABLET, EXTENDED RELEASE;ORAL600MGNoNo
002GUAIFENESINGUAIFENESINTABLET, EXTENDED RELEASE;ORAL1.2GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6986Mucus ReliefGuaifenesinMajor PharmaceuticalsANDACurrent
0904-6986Mucus ReliefGuaifenesinMajor PharmaceuticalsANDACurrent
0904-6986Mucus ReliefGuaifenesinMajor PharmaceuticalsANDACurrent
21130-206Mucus Relief MaxGuaifenesinSafewayANDACurrent
21130-206Mucus Relief MaxGuaifenesinSafewayANDACurrent
36800-226Topco Mucus ReliefGuaifenesinTopco Associates, LLCANDACurrent
36800-226Topco Mucus ReliefGuaifenesinTopco Associates, LLCANDACurrent
46122-583Maximum Strength Mucus ReliefGuaifenesinAmerisource BergenANDACurrent
46122-583Maximum Strength Mucus ReliefGuaifenesinAmerisource BergenANDACurrent
53041-190Mucus Relief 600 mgGuaifenesinGuardian Drug CompanyANDACurrent
53041-190Mucus Relief 600 mgGuaifenesinGuardian Drug CompanyANDACurrent
53041-191Mucus Relief Maximum Strength 1200 mgGuaifenesinGuardian Drug CompanyANDACurrent
53041-191Mucus Relief Maximum Strength 1200 mgGuaifenesinGuardian Drug CompanyANDACurrent
53041-233Guaifenesin Extended-Release 600 mgGuaifenesinGuardian Drug CompanyANDACurrent
53041-234Guaifenesin Extended-Release 1200 mgGuaifenesinGuardian Drug CompanyANDACurrent
62011-0382Guaifenesin Extended Release 600 mgGuaifenesinStrategic Sourcing Services LLCANDACurrent
62011-0382Guaifenesin Extended Release 600 mgGuaifenesinStrategic Sourcing Services LLCANDACurrent
62011-0382Guaifenesin Extended Release 600 mgGuaifenesinStrategic Sourcing Services LLCANDACurrent
62011-0382Guaifenesin Extended Release 600 mgGuaifenesinMcKessonANDACurrent
63629-8348Maximum Strength Mucus ReliefGuaifenesinBryant Ranch PrepackANDACurrent
63629-8348Maximum Strength Mucus ReliefGuaifenesinBryant Ranch PrepackANDACurrent
63739-067Mucus ReliefGuaifenesinMcKesson Corporation dba SKY PackagingANDACurrent
63739-067Mucus ReliefGuaifenesinMcKesson Corporation dba SKY PackagingANDACurrent
67296-1804Mucus ReliefGuaifenesinRedPharm DrugANDACurrent
67296-1804Mucus ReliefGuaifenesinRedPharm DrugANDACurrent
69230-314Mucus ReliefGuaifenesinCamber Consumer CareANDACurrent
69230-314Mucus ReliefGuaifenesinCamber Consumer CareANDACurrent
69230-315Maximum Strength Mucus ReliefGuaifenesinCamber Consumer CareANDACurrent
69230-315Maximum Strength Mucus ReliefGuaifenesinCamber Consumer CareANDACurrent
70677-0055Sunmark Mucus ReliefGuaifenesinMcKessonANDACurrent
70677-0055Sunmark Mucus ReliefGuaifenesinStrategic Sourcing Services LLCANDACurrent
70677-0055Sunmark Mucus ReliefGuaifenesinStrategic Sourcing Services LLCANDACurrent
70677-0055Sunmark Mucus ReliefGuaifenesinStrategic Sourcing Services LLCANDACurrent
71610-499Mucus ReliefGuaifenesinAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-499Mucus ReliefGuaifenesinAphena Pharma Solutions - Tennessee, LLCANDACurrent
72559-001Curist Mucus ReliefGuaifenesinLittle Pharma, Inc.ANDACurrent
72559-001Curist Mucus ReliefGuaifenesinLittle Pharma, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54891ORIG2018-07-16