Details for New Drug Application (NDA): 210322
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The generic ingredient in ISOPROTERENOL HYDROCHLORIDE is isoproterenol hydrochloride. There are seventeen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the isoproterenol hydrochloride profile page.
Summary for 210322
Tradename: | ISOPROTERENOL HYDROCHLORIDE |
Applicant: | Cipla |
Ingredient: | isoproterenol hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210322
Mechanism of Action | Adrenergic beta-Agonists |
Suppliers and Packaging for NDA: 210322
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ISOPROTERENOL HYDROCHLORIDE | isoproterenol hydrochloride | INJECTABLE;INJECTION | 210322 | ANDA | Cipla USA Inc. | 69097-521 | 69097-521-31 | 25 AMPULE in 1 CARTON (69097-521-31) / 1 mL in 1 AMPULE |
ISOPROTERENOL HYDROCHLORIDE | isoproterenol hydrochloride | INJECTABLE;INJECTION | 210322 | ANDA | Cipla USA Inc. | 69097-522 | 69097-522-35 | 10 AMPULE in 1 CARTON (69097-522-35) / 5 mL in 1 AMPULE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.2MG/ML | ||||
Approval Date: | Jun 12, 2018 | TE: | AP | RLD: | No |
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