FDA.reportPublic FDA data

Application 208369

Type
ANDA
Sponsor
DR REDDYS LABS LTD

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
0363-1604Mucus Relief DGuaifenesin and Pseudoephedrine HCLWalgreens CompanyANDACurrent
0363-1604Mucus Relief DGuaifenesin and Pseudoephedrine HCLWalgreens CompanyANDACurrent
0363-1604Mucus Relief DGuaifenesin and Pseudoephedrine HCLWalgreens CompanyANDACurrent
0363-1604Mucus Relief DGuaifenesin and Pseudoephedrine HCLWalgreens CompanyANDACurrent
0363-7064Mucus Relief DGuaifenesin and Pseudoephedrine HCLWalgreens CompanyANDACurrent
0363-7064Mucus Relief DGuaifenesin and Pseudoephedrine HCLWalgreens CompanyANDACurrent
0363-7064Mucus Relief DGuaifenesin and Pseudoephedrine HCLWalgreens CompanyANDACurrent
11822-0046Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCLRite Aid CorporationANDACurrent
11822-0046Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCLRite Aid CorporationANDACurrent
11822-7399Mucus Relief DGuaifenesin and Pseudoephedrine HCLRite Aid CorporationANDACurrent
11822-7399Mucus Relief DGuaifenesin and Pseudoephedrine HCLRite Aid CorporationANDACurrent
11822-7399Mucus Relief DGuaifenesin and Pseudoephedrine HCLRite Aid CorporationANDACurrent
49035-261Guaifenesin 1200 mg and Pseudoephedrine HCl 120 mgGuaifenesin and Pseudoephedrine HCLWal-mart Stores, Inc.ANDACurrent
49035-261Guaifenesin 1200 mg and Pseudoephedrine HCl 120 mgGuaifenesin and Pseudoephedrine HCLWal-mart Stores, Inc.ANDACurrent
55111-798Guaifenesin and Pseudoephedrine HCLGuaifenesin and Pseudoephedrine HCLDr. Reddys Laboratories LimitedANDACurrent
55111-798Guaifenesin and Pseudoephedrine HCLGuaifenesin and Pseudoephedrine HCLDr. Reddys Laboratories LimitedANDACurrent
55111-798Guaifenesin and Pseudoephedrine HCLGuaifenesin and Pseudoephedrine HCLDr. Reddys Laboratories LimitedANDACurrent
55111-799Guaifenesin and Pseudoephedrine HCLGuaifenesin and Pseudoephedrine HCLDr. Reddys Laboratories LimitedANDACurrent
55111-799Guaifenesin and Pseudoephedrine HCLGuaifenesin and Pseudoephedrine HCLDr. Reddys Laboratories LimitedANDACurrent
55111-799Guaifenesin and Pseudoephedrine HCLGuaifenesin and Pseudoephedrine HCLDr. Reddys Laboratories LimitedANDACurrent
69842-095Mucus DGuaifenesin 600 mg and Pseudoephedrine HCl 60 mgCVS Health CorpANDACurrent
69842-095Mucus DGuaifenesin 600 mg and Pseudoephedrine HCl 60 mgCVS Health CorpANDACurrent
69842-211Mucus Relief DGuaifenesin and Pseudoephedrine HCLCVS Health CorpANDACurrent
69842-211Mucus Relief DGuaifenesin and Pseudoephedrine HCLCVS Health CorpANDACurrent
69842-211Mucus Relief DGuaifenesin and Pseudoephedrine HCLCVS Health CorpANDACurrent
70000-0608Mucus Relief DGuaifenesin and Pseudoephedrine HCLCardinal HealthANDACurrent
70677-0110Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCLStrategic Sourcing Services, LLCANDACurrent
70677-0110Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCLStrategic Sourcing Services, LLCANDACurrent