Details for New Drug Application (NDA): 021936
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The generic ingredient in SPIRIVA RESPIMAT is tiotropium bromide. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tiotropium bromide profile page.
Summary for 021936
Tradename: | SPIRIVA RESPIMAT |
Applicant: | Boehringer Ingelheim |
Ingredient: | tiotropium bromide |
Patents: | 6 |
Pharmacology for NDA: 021936
Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 021936
Suppliers and Packaging for NDA: 021936
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0100 | 0597-0100-28 | 1 CARTRIDGE in 1 CARTON (0597-0100-28) / 28 SPRAY, METERED in 1 CARTRIDGE |
SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0100 | 0597-0100-51 | 1 CARTRIDGE in 1 CARTON (0597-0100-51) / 10 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: | Sep 24, 2014 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Feb 26, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 10, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 13, 2028 | Product Flag? | Substance Flag? | Delist Request? | Y |
Expired US Patents for NDA 021936
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-001 | Sep 24, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-001 | Sep 24, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-002 | Sep 15, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-001 | Sep 24, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-001 | Sep 24, 2014 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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