Details for New Drug Application (NDA): 021527
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NDA 021527 describes ATROVENT HFA, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the ATROVENT HFA profile page.
The generic ingredient in ATROVENT HFA is ipratropium bromide. There are eight drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ipratropium bromide profile page.
The generic ingredient in ATROVENT HFA is ipratropium bromide. There are eight drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ipratropium bromide profile page.
Summary for 021527
| Tradename: | ATROVENT HFA |
| Applicant: | Boehringer Ingelheim |
| Ingredient: | ipratropium bromide |
| Patents: | 1 |
Pharmacology for NDA: 021527
| Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 021527
Suppliers and Packaging for NDA: 021527
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATROVENT HFA | ipratropium bromide | AEROSOL, METERED;INHALATION | 021527 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0087 | 0597-0087-17 | 1 CANISTER in 1 CARTON (0597-0087-17) / 200 AEROSOL, METERED in 1 CANISTER |
| ATROVENT HFA | ipratropium bromide | AEROSOL, METERED;INHALATION | 021527 | NDA | RPK Pharmaceuticals, Inc. | 53002-8410 | 53002-8410-1 | 1 CANISTER in 1 CARTON (53002-8410-1) / 200 AEROSOL, METERED in 1 CANISTER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.021MG/INH | ||||
| Approval Date: | Nov 27, 2004 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 17, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 021527
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | ATROVENT HFA | ipratropium bromide | AEROSOL, METERED;INHALATION | 021527-001 | Nov 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | ATROVENT HFA | ipratropium bromide | AEROSOL, METERED;INHALATION | 021527-001 | Nov 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | ATROVENT HFA | ipratropium bromide | AEROSOL, METERED;INHALATION | 021527-001 | Nov 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | ATROVENT HFA | ipratropium bromide | AEROSOL, METERED;INHALATION | 021527-001 | Nov 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | ATROVENT HFA | ipratropium bromide | AEROSOL, METERED;INHALATION | 021527-001 | Nov 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | ATROVENT HFA | ipratropium bromide | AEROSOL, METERED;INHALATION | 021527-001 | Nov 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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