Application 076667

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL60MG;120MGNoNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-18

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIDr. Reddy's Laboratories Limited728632be-7e5c-2d06-4c95-bc8ecc9be2ec2024-12-19WarningsExact identifier
Allergy and CongestionFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIRite Aid Corporation90e1aa06-b769-e8ac-af88-1d6a256b94872020-05-19WarningsExact identifier
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIDr. Reddy's Laboratories Inc.6fd05737-d996-b5b6-dccf-bc179a9d606c2019-09-09WarningsExact identifier
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIThe Kroger Co.8cf0b878-ec13-fd44-d56f-f44af7c249ed2018-10-01WarningsExact identifier
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIThe Kroger Co.cb9e98a9-74e6-7a3e-9c5e-3bc35c4bbca62017-12-07WarningsExact identifier
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIHEB0de7fc37-7f46-4e98-d5ac-d31a3c313a622017-12-07WarningsExact identifier
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCICVS Pharmacy3e295047-1a46-a0d8-2e3f-ec4086f5aedb2015-08-24WarningsExact identifier
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIWalgreens Company37c1ce51-fb5d-7ebf-bbcd-1b2fd41d45b32015-08-04WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have difficulty swallowing Ask a doctor before use if you have heart disease thyroid disease glaucoma high blood pressure diabetes trouble urinating due to an enlarged prostate gland kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) the tablet coating may be seen in the stool (this is normal). Continue to takeas directed (see Directions). Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever you get nervous, dizzy, or sleepless If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away.

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0448Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCIWalgreens CompanyANDACurrent
0363-1606Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCIWalgreens CompanyANDACurrent
0536-1242Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCIRUGBY LABORATORIESANDACurrent
11673-032Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCITarget Brands Inc.ANDACurrent
11822-7388Allergy and CongestionFexofenadine HCl and Pseudoephedrine HCIRite Aid CorporationANDACurrent
30142-447Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCIThe Kroger Co.ANDACurrent
30142-611Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCIThe Kroger Co.ANDACurrent
30142-611Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCIThe Kroger Co.ANDACurrent
37808-022Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCIHEBANDACurrent
43598-823Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCIDr. Reddy's Laboratories Inc.ANDACurrent
43598-823Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCIDr. Reddy's Laboratories Inc.ANDACurrent
49035-273Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCIWal-mart Stores Inc.ANDACurrent
49035-273Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCIWal-mart Stores Inc.ANDACurrent
49035-273Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCIWal-mart Stores Inc.ANDACurrent
55111-447Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCIDr. Reddy's Laboratories LimitedANDACurrent
55111-447Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCIDr. Reddy's Laboratories LimitedANDACurrent
59779-508Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCICVS PharmacyANDACurrent
62011-0455Allergy and CongestionFexofenadine HCl and Pseudoephedrine HCIStrategic Sourcing Services, LLCANDACurrent
62011-0455Allergy and CongestionFexofenadine HCl and Pseudoephedrine HCIStrategic Sourcing Services, LLCANDACurrent
62011-0455Allergy and CongestionFexofenadine HCl and Pseudoephedrine HCIStrategic Sourcing Services, LLCANDACurrent
69842-249Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCICVS PharmacyANDACurrent
69842-249Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCICVS PharmacyANDACurrent
70000-051812HR Allergy and Congestion ReliefFexofenadine HCl and Pseudoephedrine HCICardinal HealthANDACurrent
70000-051812HR Allergy and Congestion ReliefFexofenadine HCl and Pseudoephedrine HCICardinal HealthANDACurrent
70000-051812HR Allergy and Congestion ReliefFexofenadine HCl and Pseudoephedrine HCICardinal HealthANDACurrent