|
Midazolam HclDrug - Midazolam Hcl The trade name of the product as shown on the labeling.
Dosage -
SYRUP; ORAL
Active Ingredient(s) -
Midazolam Hydrochloride
Strength -
EQ 2MG BASE/ML
Applicant -
ROXANE
New Drug Application (NDA) Number -
075873
Product Number -
001
Therapeutic Equivalence (TE) Code -
AA
Approval Date -
Apr 30, 2002
Reference Listed Drug (RLD) -
Yes
Type -
RX
Applicant Full Name -
Roxane Laboratories Inc
Midazolam Hcl
Versed Eq 5mg Base/ml Injectable; Injection
Midazolam Hcl Eq 2mg Base/ml Syrup; Oral Midazolam Hcl Eq 2mg Base/ml Syrup; Oral Midazolam Hcl Eq 2mg Base/ml Syrup; Oral Midazolam Hcl Eq 2mg Base/ml Syrup; Oral Midazolam Hcl Eq 2mg Base/ml Syrup; Oral Midazolam Hcl Eq 5mg Base/ml Injectable; Injection Midazolam Hcl Eq 1mg Base/ml Injectable; Injection Midazolam Hcl Eq 5mg Base/ml Injectable; Injection Versed Eq 1mg Base/ml Injectable; Injection NewDrugInformation |