FDA.reportPublic FDA data

Application 021282

Type
NDA
Sponsor
RB HLTH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MUCINEXGUAIFENESINTABLET, EXTENDED RELEASE;ORAL600MGYesNo
002MUCINEXGUAIFENESINTABLET, EXTENDED RELEASE;ORAL1.2GMYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0071MucusGuaifenesinwalgreensNDACurrent
0363-0074MucusGuaifenesinwalgreensNDACurrent
17856-0008MucinexGuaifenesinAtlantic Biologicals CorpsNDACurrent
17856-0008MucinexGuaifenesinAtlantic Biologicals CorpsNDACurrent
17856-0008MucinexGuaifenesinAtlantic Biologicals CorpsNDACurrent
17856-0008MucinexGuaifenesinAtlantic Biologicals CorpsNDACurrent
21695-870MucinexGuaifenesinRebel Distributors CorpNDACurrent
30142-701MucusGuaifenesinKROGER COMPANYNDACurrent
30142-701MucusGuaifenesinKROGER COMPANYNDACurrent
30142-701MucusGuaifenesinKROGER COMPANYNDACurrent
30142-703GuaifenesinGuaifenesinKROGER COMPANYNDACurrent
30142-703GuaifenesinGuaifenesinKROGER COMPANYNDACurrent
30142-703GuaifenesinGuaifenesinKROGER COMPANYNDACurrent
46122-416MucusGuaifenesinAMERISOURCEBERGEN DRUG CORPORATIONNDACurrent
46122-416MucusGuaifenesinAMERISOURCEBERGEN DRUG CORPORATIONNDACurrent
46122-416MucusGuaifenesinAMERISOURCEBERGEN DRUG CORPORATIONNDACurrent
46122-417MucusGuaifenesinAMERISOURCEBERGEN DRUG CORPORATIONNDACurrent
49035-070MucusGuaifenesinWALMART STORES, INC.NDACurrent
49035-070MucusGuaifenesinWALMART STORES, INC.NDACurrent
49035-074GuaifenesinGuaifenesinWALMART STORES, INC.NDACurrent
49035-074GuaifenesinGuaifenesinWALMART STORES, INC.NDACurrent
50090-0818MucinexGuaifenesinA-S Medication SolutionsNDACurrent
50090-0818MucinexGuaifenesinA-S Medication SolutionsNDACurrent
50090-1340MucinexGuaifenesinA-S Medication SolutionsNDACurrent
50090-1340MucinexGuaifenesinA-S Medication SolutionsNDACurrent
50090-1340MucinexGuaifenesinA-S Medication SolutionsNDACurrent
50090-2301MucinexGuaifenesinA-S Medication SolutionsNDACurrent
50090-2301MucinexGuaifenesinA-S Medication SolutionsNDACurrent
50090-2301MucinexGuaifenesinA-S Medication SolutionsNDACurrent
50090-2301MucinexGuaifenesinA-S Medication SolutionsNDACurrent
50090-2380MucinexGuaifenesinA-S Medication SolutionsNDACurrent
50090-2380MucinexGuaifenesinA-S Medication SolutionsNDACurrent
51316-070GUAIFENESINGuaifenesinCVS PHARMACY, INCNDACurrent
51660-070GUAIFENESINGuaifenesinOHM LABORATORIES INCNDACurrent
51660-070GUAIFENESINGuaifenesinOHM LABORATORIES INCNDACurrent
51660-072GuaifenesinGuaifenesinOHM LABORATORIES INCNDACurrent
53808-0871MucinexGuaifenesinState of Florida DOH Central PharmacyNDACurrent
55045-3143MUCINEXGUAIFENESINDispensing Solutions, Inc.NDACurrent
55154-4680MucinexGuaifenesinCardinal Health 107, LLCNDACurrent
55154-4680MucinexGuaifenesinCardinal HealthNDACurrent
55289-087MucinexGuaifenesinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-087MucinexGuaifenesinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-087MucinexGuaifenesinPD-Rx Pharmaceuticals, Inc.NDACurrent
55700-489MucinexGuaifenesinLake Erie Medical DBA Quality Care Products LLCNDACurrent
61919-651MUCINEXMUCINEXDIRECT RXNDACurrent
61919-651MUCINEXMUCINEXDIRECT RXNDACurrent
62011-0347MucusGuaifenesinMCKESSON (HEALTH MART)NDACurrent
63187-954MucinexGuaifenesinProficient Rx LPNDACurrent
63187-954MucinexGuaifenesinProficient Rx LPNDACurrent
63187-954MucinexGuaifenesinProficient Rx LPNDACurrent
63629-7115MucinexGuaifenesinBryant Ranch PrepackNDACurrent
63629-7115MucinexGuaifenesinBryant Ranch PrepackNDACurrent
63629-7115MucinexGuaifenesinBryant Ranch PrepackNDACurrent
63629-7115MucinexGuaifenesinBryant Ranch PrepackNDACurrent
63629-7886MucinexGuaifenesinBryant Ranch PrepackNDACurrent
63629-7886MucinexGuaifenesinBryant Ranch PrepackNDACurrent
63629-7886MucinexGuaifenesinBryant Ranch PrepackNDACurrent
63629-7886MucinexGuaifenesinBryant Ranch PrepackNDACurrent
63824-008MucinexGuaifenesinRB Health (US) LLCNDACurrent
63824-008MucinexGuaifenesinRB Health (US) LLCNDACurrent
63824-008MucinexGuaifenesinRB Health (US) LLCNDACurrent
63824-008MucinexGuaifenesinRB Health (US) LLCNDACurrent
63824-023MucinexGuaifenesinRB Health (US) LLCNDACurrent
63824-023MucinexGuaifenesinRB Health (US) LLCNDACurrent
63824-023MucinexGuaifenesinRB Health (US) LLCNDACurrent
63824-023MucinexGuaifenesinReckitt Benckiser LLCNDACurrent
63868-389MucusGuaifenesinCHAIN DRUG MARKETING ASSOCIATION INCNDACurrent
63868-390GuaifenesinGuaifenesinCHAIN DRUG MARKETING ASSOCIATION INCNDACurrent
67296-0569MucinexGuaifenesinRedPharm Drug, Inc.NDACurrent
67544-149MucinexGuaifenesinAphena Pharma Solutions - Tennessee, LLCNDACurrent
68084-572MucinexGuaifenesinAmerican Health PackagingNDACurrent
68084-572MucinexGuaifenesinAmerican Health PackagingNDACurrent
68084-572MucinexGuaifenesinAmerican Health PackagingNDACurrent
68196-072GuaifenesinGuaifenesinSAM'S WEST INCNDACurrent
69842-016GuaifenesinGuaifenesinCVS PHARMACYNDACurrent
70518-0228MucinexGuaifenesinREMEDYREPACK INC.NDACurrent
70518-0228MucinexGuaifenesinREMEDYREPACK INC.NDACurrent
70518-0228MucinexGuaifenesinREMEDYREPACK INC.NDACurrent
70518-0228MucinexGuaifenesinREMEDYREPACK INC.NDACurrent
70518-0228MucinexGuaifenesinREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79531SUPPL 2024-09-03
79526SUPPL 2024-09-03
68307SUPPL2021-08-06
66337SUPPL2021-02-23
66331SUPPL2021-02-23
64276SUPPL2020-08-13
60157SUPPL2019-09-30
60156SUPPL2019-09-30
60155SUPPL2019-09-30
60154SUPPL2019-09-30
60153SUPPL2019-09-30
54607SUPPL2018-06-19
48920SUPPL2017-07-06
48917SUPPL2017-07-06
27358SUPPL2014-03-07
4887SUPPL2014-03-07
4886SUPPL2009-04-07
27357SUPPL2008-08-22
36561SUPPL2007-09-07
27356SUPPL2007-09-07
27355SUPPL2006-11-22
4885SUPPL2006-09-18
4884SUPPL2002-12-18
21572ORIG2002-11-25
36560ORIG2002-07-12
27354ORIG2002-07-12