Details for New Drug Application (NDA): 205636
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The generic ingredient in PROAIR RESPICLICK is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.
Summary for 205636
| Tradename: | PROAIR RESPICLICK |
| Applicant: | Teva Branded Pharm |
| Ingredient: | albuterol sulfate |
| Patents: | 0 |
Pharmacology for NDA: 205636
| Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 205636
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROAIR DIGIHALER | albuterol sulfate | POWDER, METERED;INHALATION | 205636 | NDA | Teva Respiratory, LLC | 59310-117 | 59310-117-20 | 1 INHALER in 1 BOX (59310-117-20) / 200 INHALANT in 1 INHALER |
| PROAIR DIGIHALER | albuterol sulfate | POWDER, METERED;INHALATION | 205636 | NDA | Teva Respiratory, LLC | 59310-540 | 59310-540-20 | 1 INHALER in 1 BOX (59310-540-20) / 200 POWDER, METERED in 1 INHALER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER, METERED;INHALATION | Strength | EQ 0.09MG BASE/INH | ||||
| Approval Date: | Mar 31, 2015 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER, METERED;INHALATION | Strength | EQ 0.09MG BASE/INH | ||||
| Approval Date: | Dec 21, 2018 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 205636
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Teva Branded Pharm | PROAIR RESPICLICK | albuterol sulfate | POWDER, METERED;INHALATION | 205636-001 | Mar 31, 2015 | ⤷ Get Started Free | ⤷ Get Started Free |
| Teva Branded Pharm | PROAIR DIGIHALER | albuterol sulfate | POWDER, METERED;INHALATION | 205636-002 | Dec 21, 2018 | ⤷ Get Started Free | ⤷ Get Started Free |
| Teva Branded Pharm | PROAIR RESPICLICK | albuterol sulfate | POWDER, METERED;INHALATION | 205636-001 | Mar 31, 2015 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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