Details for New Drug Application (NDA): 210322
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NDA 210322 describes ISOPROTERENOL HYDROCHLORIDE, which is a drug marketed by 3M, Alpharma Us Pharms, Abraxis Pharm, Am Regent, Amneal, Amphastar Pharms Inc, Amring Pharms, Avet Lifesciences, Baxter Hlthcare, Cipla, Eugia Pharma, Gland Pharma Ltd, Hikma, Hospira, Intl Medication, Micro Labs, Nexus, Norvium Bioscience, Penn Life, Somerset Theraps Llc, Zydus Pharms, Armour Pharm, DEY, and Parke Davis, and is included in twenty-eight NDAs. It is available from thirteen suppliers. Additional details are available on the ISOPROTERENOL HYDROCHLORIDE profile page.
The generic ingredient in ISOPROTERENOL HYDROCHLORIDE is isoproterenol hydrochloride. There are seventeen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the isoproterenol hydrochloride profile page.
The generic ingredient in ISOPROTERENOL HYDROCHLORIDE is isoproterenol hydrochloride. There are seventeen drug master file entries for this compound. Thirteen 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 |
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: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 0.2MG/ML | ||||
| Approval Date: | Jun 12, 2018 | TE: | RLD: | No | |||||
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