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-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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Teva Branded Pharm | PROAIR DIGIHALER | albuterol sulfate | POWDER, METERED;INHALATION | 205636-002 | Dec 21, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Teva Branded Pharm | PROAIR RESPICLICK | albuterol sulfate | POWDER, METERED;INHALATION | 205636-001 | Mar 31, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Teva Branded Pharm | PROAIR DIGIHALER | albuterol sulfate | POWDER, METERED;INHALATION | 205636-002 | Dec 21, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Teva Branded Pharm | PROAIR RESPICLICK | albuterol sulfate | POWDER, METERED;INHALATION | 205636-001 | Mar 31, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Teva Branded Pharm | PROAIR RESPICLICK | albuterol sulfate | POWDER, METERED;INHALATION | 205636-001 | Mar 31, 2015 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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