FDA.reportPublic FDA data

Application 091071

Type
ANDA
Sponsor
ACTAVIS LABS FL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL600MG;60MGNoNo
002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL1.2GM;120MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-2002Mucus DGuaifenesin, pseudoephedrine hydrochlorideL. Perrigo CompanyANDACurrent
0113-2002Mucus DGuaifenesin, pseudoephedrine hydrochlorideL. Perrigo CompanyANDACurrent
0363-0144Mucus Relief DGuaifenesin, pseudoephedrine hydrochlorideWalgreen CompanyANDACurrent
0363-0144Mucus Relief DGuaifenesin, pseudoephedrine hydrochlorideWalgreen CompanyANDACurrent
0536-1205rugby mucus relief dGuaifenesin, pseudoephedrine hydrochlorideRugby LaboratoriesANDACurrent
11822-0144mucus relief dGuaifenesin, pseudoephedrine hydrochlorideRite Aid CorporationANDACurrent
11822-0144mucus relief dGuaifenesin, pseudoephedrine hydrochlorideRite Aid CorporationANDACurrent
30142-144Mucus DGuaifenesin, pseudoephedrine hydrochlorideKroger CompanyANDACurrent
30142-144Mucus DGuaifenesin, pseudoephedrine hydrochlorideKroger CompanyANDACurrent
30142-144Mucus DGuaifenesin, pseudoephedrine hydrochlorideKroger CompanyANDACurrent
30142-144Mucus DGuaifenesin, pseudoephedrine hydrochlorideKroger CompanyANDACurrent
36800-144TopCare Mucus DGuaifenesin, pseudoephedrine hydrochlorideTopco Associates LLCANDACurrent
37808-446Mucus Relief DGuaifenesin, pseudoephedrine hydrochlorideH E BANDACurrent
37808-446Mucus Relief DGuaifenesin, pseudoephedrine hydrochlorideH E BANDACurrent
37808-777mucus relief dGuaifenesin, pseudoephedrine hydrochlorideH E BANDACurrent
37808-777mucus relief dGuaifenesin, pseudoephedrine hydrochlorideH E BANDACurrent
41250-144Mucus DGuaifenesin, pseudoephedrine hydrochlorideMeijer Distribution IncANDACurrent
45802-230Guaifenesin and pseudoephedrine hydrochloride Extended ReleaseGuaifenesin, pseudoephedrine hydrochloridePerrigo New York IncANDACurrent
45802-230Guaifenesin and pseudoephedrine hydrochloride Extended ReleaseGuaifenesin, pseudoephedrine hydrochloridePerrigo New York IncANDACurrent
45802-230Guaifenesin and pseudoephedrine hydrochloride Extended ReleaseGuaifenesin, pseudoephedrine hydrochloridePadagis Israel Pharmaceuticals LtdANDACurrent
46122-239Good Neighbor Pharmacy Mucus DGuaifenesin, pseudoephedrine hydrochlorideAmerisource BergenANDACurrent
49035-729equate mucus dguaifenesin, pseudoephedrine hydrochlorideWal-Mart Stores IncANDACurrent
49035-792equate mucus dguaifenesin, pseudoephedrine hydrochlorideWal-Mart Stores IncANDACurrent
49348-113Sunmark mucus relief dGuaifenesin, pseudoephedrine hydrochlorideMcKessonANDACurrent
49348-113Sunmark mucus relief dGuaifenesin, pseudoephedrine hydrochlorideStrategic Sourcing Services LLCANDACurrent
49348-113Sunmark mucus relief dGuaifenesin, pseudoephedrine hydrochlorideStrategic Sourcing Services LLCANDACurrent
55316-144healthy accents mucus relief DGuaifenesin, pseudoephedrine hydrochlorideDZA Brands LLCANDACurrent
56062-144Mucus D ERGuaifenesin, pseudoephedrine hydrochloridePublix Super Markets IncANDACurrent
56062-144Mucus D ERGuaifenesin, pseudoephedrine hydrochloridePublix Super Markets IncANDACurrent
59779-825Mucus DGuaifenesin, pseudoephedrine hydrochlorideCVS PharmacyANDACurrent
59779-825Mucus DGuaifenesin, pseudoephedrine hydrochlorideCVS PharmacyANDACurrent
62011-0259Health Mart mucus relief dGuaifenesin, pseudoephedrine hydrochlorideStrategic Sourcing Services LLCANDACurrent
62011-0259Health Mart mucus relief dGuaifenesin, pseudoephedrine hydrochlorideMcKessonANDACurrent
62011-0259Health Mart mucus relief dGuaifenesin, pseudoephedrine hydrochlorideStrategic Sourcing Services LLCANDACurrent
63187-960Guaifenesin and pseudoephedrine hydrochloride Extended ReleaseGuaifenesin, pseudoephedrine hydrochlorideProficient Rx LPANDACurrent
63187-960Guaifenesin and pseudoephedrine hydrochloride Extended ReleaseGuaifenesin, pseudoephedrine hydrochlorideProficient Rx LPANDACurrent
69256-144Harris Teeter Mucus Relief DGuaifenesin, pseudoephedrine hydrochlorideHarris Teeter, LLCANDACurrent
69256-144Harris Teeter Mucus Relief DGuaifenesin, pseudoephedrine hydrochlorideHarris Teeter, LLCANDACurrent
70000-0004leader mucus relief dGuaifenesin, pseudoephedrine hydrochlorideCardinal HealthANDACurrent
70000-0004leader mucus relief dGuaifenesin, pseudoephedrine hydrochlorideCardinal Health 110, LLC. dba LeaderANDACurrent
70518-0011Guaifenesin and pseudoephedrine hydrochloride Extended ReleaseGuaifenesin, pseudoephedrine hydrochlorideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31514ORIG2015-06-02