Details for New Drug Application (NDA): 075826
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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 075826
Tradename: | PROPRANOLOL HYDROCHLORIDE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | propranolol hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075826
Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 075826
Suppliers and Packaging for NDA: 075826
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROPRANOLOL HYDROCHLORIDE | propranolol hydrochloride | INJECTABLE;INJECTION | 075826 | ANDA | Fresenius Kabi USA, LLC | 63323-604 | 63323-604-01 | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-604-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
PROPRANOLOL HYDROCHLORIDE | propranolol hydrochloride | INJECTABLE;INJECTION | 075826 | ANDA | Medical Purchasing Solutions, LLC | 71872-7195 | 71872-7195-1 | 1 VIAL, SINGLE-DOSE in 1 BAG (71872-7195-1) / 1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
Approval Date: | Aug 31, 2001 | TE: | AP | RLD: | No |
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