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RozeremDrug - Rozerem The trade name of the product as shown on the labeling.
Dosage -
TABLET; ORAL
Active Ingredient(s) -
Ramelteon
Strength -
8MG
Applicant -
TAKEDA GLOBAL
New Drug Application (NDA) Number -
021782
Product Number -
001
Therapeutic Equivalence (TE) Code -
Approval Date -
Jul 22, 2005
Reference Listed Drug (RLD) -
Yes
Type -
RX
Applicant Full Name -
Takeda Global Research Development Center Inc
Rozerem
Quinine Sulfate 324mg Capsule; Oral
Aciphex 10mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Tablet, Delayed Release; Oral Aciphex 20mg Tablet, Delayed Release; Oral Evista 60mg Tablet; Oral Rozerem 8mg Tablet; Oral Quinidine Sulfate 300mg Tablet; Oral Quinidine Sulfate 200mg Tablet; Oral Quinidine Sulfate 200mg Tablet; Oral Quinora 200mg Tablet; Oral Quinora 300mg Tablet; Oral NewDrugInformation |