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Pseudoephedrine HydrochlorideDrug - Pseudoephedrine Hydrochloride The trade name of the product as shown on the labeling.
Dosage -
TABLET, EXTENDED RELEASE; ORAL
Active Ingredient(s) -
Pseudoephedrine Hydrochloride
Strength -
120MG
Applicant -
RANBAXY
New Drug Application (NDA) Number -
077442
Product Number -
001
Therapeutic Equivalence (TE) Code -
Approval Date -
Sep 28, 2005
Reference Listed Drug (RLD) -
No
Type -
OTC
Applicant Full Name -
Ranbaxy Laboratories Ltd
Pseudoephedrine Hydrochloride
Vivactil 5mg Tablet; Oral
Novafed 120mg Capsule, Extended Release; Oral Sudafed 12 Hour 120mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Capsule, Extended Release; Oral Efidac 24 Pseudoephedrine Hcl 240mg Tablet, Extended Release; Oral Pseudoephedrine Hcl 120mg Tablet, Extended Release; Oral Pseudoephedrine Hydrochloride 120mg Tablet, Extended Release; Oral Ventaire 2mg Tablet; Oral Vivactil 10mg Tablet; Oral Vivactil 10mg Tablet; Oral Vivactil 5mg Tablet; Oral NewDrugInformation |