Details for New Drug Application (NDA): 203108
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NDA 203108 describes STRIVERDI RESPIMAT, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the STRIVERDI RESPIMAT profile page.
The generic ingredient in STRIVERDI RESPIMAT is olodaterol hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the olodaterol hydrochloride profile page.
The generic ingredient in STRIVERDI RESPIMAT is olodaterol hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the olodaterol hydrochloride profile page.
Summary for 203108
| Tradename: | STRIVERDI RESPIMAT |
| Applicant: | Boehringer Ingelheim |
| Ingredient: | olodaterol hydrochloride |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203108
Generic Entry Date for 203108*:
Constraining patent/regulatory exclusivity:
Dosage:
SPRAY, METERED;INHALATION |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 203108
| Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 203108
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| STRIVERDI RESPIMAT | olodaterol hydrochloride | SPRAY, METERED;INHALATION | 203108 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0192 | 0597-0192-61 | 1 CARTRIDGE in 1 CARTON (0597-0192-61) / 60 SPRAY, METERED in 1 CARTRIDGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;INHALATION | Strength | EQ 0.0025MG BASE/INH | ||||
| Approval Date: | Jul 31, 2014 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 19, 2027 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Expired US Patents for NDA 203108
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