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Details for New Drug Application (NDA): 208437
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NDA 208437 describes LONHALA MAGNAIR KIT, which is a drug marketed by Sunovion Resp and is included in one NDA. It is available from two suppliers. There are twelve 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. Forty-three 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. Forty-three suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
Summary for 208437
| Tradename: | LONHALA MAGNAIR KIT |
| Applicant: | Sunovion Resp |
| Ingredient: | glycopyrrolate |
| Patents: | 12 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208437
| Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 208437
Suppliers and Packaging for NDA: 208437
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LONHALA MAGNAIR KIT | glycopyrrolate | SOLUTION;INHALATION | 208437 | NDA | Holopack Verpackungstechnik GmbH | 60940-024 | 60940-024-01 | 432 POUCH in 1 CARTON (60940-024-01) > 2 VIAL in 1 POUCH > 1 mL in 1 VIAL |
| LONHALA MAGNAIR KIT | glycopyrrolate | SOLUTION;INHALATION | 208437 | NDA | Sunovion Pharmaceuticals Inc. | 63402-201 | 63402-201-00 | 1 CARTON in 1 KIT (63402-201-00) > 30 POUCH in 1 CARTON > 2 VIAL, SINGLE-DOSE in 1 POUCH > 1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 25MCG/ML | ||||
| Approval Date: | Dec 5, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 5, 2020 | ||||||||
| Regulatory Exclusivity Use: | |||||||||
| Patent: | Start Trial | Patent Expiration: | Sep 14, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Nov 12, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 208437
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sunovion Resp | LONHALA MAGNAIR KIT | glycopyrrolate | SOLUTION;INHALATION | 208437-001 | Dec 5, 2017 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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