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ApresolineDrug - Apresoline The trade name of the product as shown on the labeling.
Dosage -
TABLET; ORAL
Active Ingredient(s) -
Hydralazine Hydrochloride
Strength -
10MG
Applicant -
NOVARTIS
New Drug Application (NDA) Number -
008303
Product Number -
004
Therapeutic Equivalence (TE) Code -
AA
Approval Date -
Approved Prior to Jan 1, 1982
Reference Listed Drug (RLD) -
Yes
Type -
RX
Applicant Full Name -
Novartis Pharmaceuticals Corp
Apresoline
Hydralazine Hcl 20mg/ml Injectable; Injection
Hydralazine Hcl 20mg/ml Injectable; Injection Hydralazine Hcl 20mg/ml Injectable; Injection Hydralazine Hcl 20mg/ml Injectable; Injection Apresoline 100mg Tablet; Oral Apresoline 10mg Tablet; Oral Wydase 150 Units/vial **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Injectable; Injection Apresoline 20mg/ml Injectable; Injection Hydralazine Hcl 20mg/ml Injectable; Injection Hydralazine Hcl 20mg/ml Injectable; Injection NewDrugInformation |