Details for New Drug Application (NDA): 205636
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NDA 205636 describes PROAIR RESPICLICK, which is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the PROAIR RESPICLICK profile page.
The generic ingredient in PROAIR RESPICLICK is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.
The generic ingredient in PROAIR RESPICLICK is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-four 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: | 22 |
| Formulation / Manufacturing: | see details |
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 RESPICLICK | 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 |
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 | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 18, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 18, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 1, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 205636
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