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ALBUTEROL SULFATE Drug Profile
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Albuterol Sulfate is a drug marketed by Cipla, Perrigo Pharms Co, Actavis Mid Atlantic, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Copley Pharm, Hi Tech Pharma, Landela Pharm, Mylan Speclt, Nephron, Ritedose Corp, Roxane, Sun Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Amneal Pharms, Cosette, Lannett Co Inc, Mova, Quagen, Teva, Vistapharm, Mylan, Am Therap, Amneal Pharms Co, Appco, Arise, Dava Pharms Inc, Pliva, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Yaopharma Co Ltd, Fosun Pharma, and Watson Labs Teva. and is included in seventy-four NDAs.
The generic ingredient in ALBUTEROL SULFATE is albuterol sulfate; ipratropium bromide. There are thirty-eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.
Summary for ALBUTEROL SULFATE
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Pharmacology for ALBUTEROL SULFATE
| Drug Class | beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists |
Paragraph IV (Patent) Challenges for ALBUTEROL SULFATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PROVENTIL-HFA | AEROSOL, METERED;INHALATION | albuterol sulfate | 020503 | 2015-05-20 |
| PROAIR HFA | AEROSOL, METERED;INHALATION | albuterol sulfate | 021457 | 2012-05-18 |
| ACCUNEB | SOLUTION;INHALATION | albuterol sulfate | 020949 | 2005-10-19 |
| VOLMAX | TABLET, EXTENDED RELEASE;ORAL | albuterol sulfate | 019604 | |
| VENTOLIN | SYRUP;ORAL | albuterol sulfate | 019621 |
US Patents and Regulatory Information for ALBUTEROL SULFATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Warner Chilcott | ALBUTEROL SULFATE | albuterol sulfate | TABLET;ORAL | 072818-001 | Jan 9, 1990 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Mylan | ALBUTEROL SULFATE | albuterol sulfate | TABLET, EXTENDED RELEASE;ORAL | 078092-002 | Jan 29, 2007 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Amneal Pharms | ALBUTEROL SULFATE | albuterol sulfate | SYRUP;ORAL | 079241-001 | May 12, 2010 | AA | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Watson Labs Teva | ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE | albuterol sulfate; ipratropium bromide | SOLUTION;INHALATION | 077063-001 | Dec 31, 2007 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
