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 two suppliers. There are nine 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-five 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-five 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: | 21 |
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 | RPK Pharmaceuticals, Inc. | 53002-1750 | 53002-1750-1 | 1 INHALER in 1 BOX (53002-1750-1) / 200 POWDER, METERED in 1 INHALER |
| PROAIR RESPICLICK | albuterol sulfate | POWDER, METERED;INHALATION | 205636 | NDA | RPK Pharmaceuticals, Inc. | 53002-1750 | 53002-1750-1 | 1 INHALER in 1 BOX (53002-1750-1) / 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 | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 18, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 18, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 1, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 205636
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