Details for New Drug Application (NDA): 021936
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NDA 021936 describes SPIRIVA RESPIMAT, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the SPIRIVA RESPIMAT profile page.
The generic ingredient in SPIRIVA RESPIMAT is tiotropium bromide. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the tiotropium bromide profile page.
The generic ingredient in SPIRIVA RESPIMAT is tiotropium bromide. There are eight drug master file entries for this compound. Two 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: | 7 |
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: | See Plans and Pricing | Patent Expiration: | Feb 26, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | See Plans and Pricing | Patent Expiration: | Apr 10, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | See Plans and Pricing | 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 | See Plans and Pricing | See Plans and Pricing |
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-001 | Sep 24, 2014 | See Plans and Pricing | See Plans and Pricing |
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-002 | Sep 15, 2015 | See Plans and Pricing | See Plans and Pricing |
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-002 | Sep 15, 2015 | See Plans and Pricing | See Plans and Pricing |
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-002 | Sep 15, 2015 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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