Details for New Drug Application (NDA): 070690
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The generic ingredient in PROPRANOLOL HYDROCHLORIDE is hydrochlorothiazide; propranolol hydrochloride. There are thirty-two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; propranolol hydrochloride profile page.
Summary for 070690
Tradename: | PROPRANOLOL HYDROCHLORIDE |
Applicant: | Hikma |
Ingredient: | propranolol hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 070690
Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 070690
Suppliers and Packaging for NDA: 070690
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROPRANOLOL HYDROCHLORIDE | propranolol hydrochloride | SOLUTION;ORAL | 070690 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-3730 | 0054-3730-63 | 500 mL in 1 BOTTLE, PLASTIC (0054-3730-63) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 40MG/5ML | ||||
Approval Date: | May 15, 1987 | TE: | RLD: | No |
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