Details for New Drug Application (NDA): 208437
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NDA 208437 describes LONHALA MAGNAIR KIT, which is a drug marketed by Sumitomo Pharma Am and is included in one NDA. There are eleven patents protecting this drug. Additional details are available on the LONHALA MAGNAIR KIT profile page.
The generic ingredient in LONHALA MAGNAIR KIT is glycopyrrolate. There are seventeen drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
The generic ingredient in LONHALA MAGNAIR KIT is glycopyrrolate. There are seventeen drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
Summary for 208437
| Tradename: | LONHALA MAGNAIR KIT |
| Applicant: | Sumitomo Pharma Am |
| Ingredient: | glycopyrrolate |
| Patents: | 11 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 208437
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INHALATION | Strength | 25MCG/ML | ||||
| Approval Date: | Dec 5, 2017 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 14, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 12, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Dec 7, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | A METHOD OF USING AN AEROSOL DELIVERY DEVICE TO AEROSOLIZE GLYCOPYRROLATE FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) | ||||||||
Expired US Patents for NDA 208437
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sumitomo Pharma Am | LONHALA MAGNAIR KIT | glycopyrrolate | SOLUTION;INHALATION | 208437-001 | Dec 5, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
| Sumitomo Pharma Am | LONHALA MAGNAIR KIT | glycopyrrolate | SOLUTION;INHALATION | 208437-001 | Dec 5, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
| Sumitomo Pharma Am | LONHALA MAGNAIR KIT | glycopyrrolate | SOLUTION;INHALATION | 208437-001 | Dec 5, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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