Details for New Drug Application (NDA): 213657
✉ Email this page to a colleague
NDA 213657 describes ALBUTEROL SULFATE, which is a drug marketed by Armstrong Pharms, Cipla, Lupin, Padagis Us, Sandoz, Actavis Mid Atlantic, Apotex Inc, Bausch, Copley Pharm, Epic Pharma Llc, Landela Pharm, Lexenpharm, Luoxin Aurovitas, Nephron, Norvium Bioscience, Ritedose Corp, Roxane, Sentiss, Sun Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Amneal Pharms, Chartwell Molecular, Chartwell Rx, Cosette, Hikma, Mova, Quagen, Teva, Rising, Aizant, Am Therap, Amneal Pharms Co, Aurobindo Pharma Ltd, Dash Pharms Natco, Hibrow Hlthcare, Pliva, Strides Pharma, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Zydus Pharms, Aiping Pharm Inc, and Watson Labs Teva, and is included in eighty-two NDAs. It is available from thirty-eight 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. Fifteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.
Summary for 213657
| Tradename: | ALBUTEROL SULFATE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | albuterol sulfate |
| Patents: | 0 |
Pharmacology for NDA: 213657
| Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 213657
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALBUTEROL SULFATE | albuterol sulfate | TABLET;ORAL | 213657 | ANDA | Aurobindo Pharma Limited | 59651-333 | 59651-333-01 | 100 TABLET in 1 BOTTLE (59651-333-01) |
| ALBUTEROL SULFATE | albuterol sulfate | TABLET;ORAL | 213657 | ANDA | Aurobindo Pharma Limited | 59651-333 | 59651-333-05 | 500 TABLET in 1 BOTTLE (59651-333-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | May 14, 2020 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE | ||||
| Approval Date: | May 14, 2020 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
