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Details for New Drug Application (NDA): 207857
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NDA 207857 describes ALBUTEROL SULFATE, which is a drug marketed by Cipla, Lupin, Perrigo Pharms Co, Actavis Mid Atlantic, Akorn, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Copley Pharm, 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, Arise, Dava Pharms Inc, Eywa, Pliva, Rising, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Yaopharma Co Ltd, Zydus Pharms, Fosun Pharma, and Watson Labs Teva, and is included in seventy-nine NDAs. It is available from thirty-one suppliers. Additional details are available on the ALBUTEROL SULFATE profile page.
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.
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 207857
| Tradename: | ALBUTEROL SULFATE |
| Applicant: | Sun Pharm |
| Ingredient: | albuterol sulfate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | EQ 0.083% BASE | ||||
| Approval Date: | Jul 21, 2017 | TE: | AN | RLD: | No | ||||
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