Details for New Drug Application (NDA): 022007
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NDA 022007 describes PERFOROMIST, which is a drug marketed by Viatris Specialty and is included in one NDA. It is available from two suppliers. Additional details are available on the PERFOROMIST profile page.
The generic ingredient in PERFOROMIST is formoterol fumarate. There are nineteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the formoterol fumarate profile page.
The generic ingredient in PERFOROMIST is formoterol fumarate. There are nineteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the formoterol fumarate profile page.
Summary for 022007
| Tradename: | PERFOROMIST |
| Applicant: | Viatris Specialty |
| Ingredient: | formoterol fumarate |
| Patents: | 0 |
Pharmacology for NDA: 022007
| Mechanism of Action | Adrenergic beta2-Agonists |
Medical Subject Heading (MeSH) Categories for 022007
Suppliers and Packaging for NDA: 022007
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PERFOROMIST | formoterol fumarate | SOLUTION;INHALATION | 022007 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 0378-1631 | 0378-1631-91 | 60 POUCH in 1 CARTON (0378-1631-91) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL |
| PERFOROMIST | formoterol fumarate | SOLUTION;INHALATION | 022007 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 0378-1631 | 0378-1631-93 | 30 POUCH in 1 CARTON (0378-1631-93) / 1 VIAL in 1 POUCH (0378-1631-32) / 2 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 0.02MG/2ML | ||||
| Approval Date: | May 11, 2007 | TE: | AN | RLD: | Yes | ||||
Expired US Patents for NDA 022007
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viatris Specialty | PERFOROMIST | formoterol fumarate | SOLUTION;INHALATION | 022007-001 | May 11, 2007 | 6,667,344 | ⤷ Get Started Free |
| Viatris Specialty | PERFOROMIST | formoterol fumarate | SOLUTION;INHALATION | 022007-001 | May 11, 2007 | 9,730,890 | ⤷ Get Started Free |
| Viatris Specialty | PERFOROMIST | formoterol fumarate | SOLUTION;INHALATION | 022007-001 | May 11, 2007 | 7,462,645 | ⤷ Get Started Free |
| Viatris Specialty | PERFOROMIST | formoterol fumarate | SOLUTION;INHALATION | 022007-001 | May 11, 2007 | 8,623,922 | ⤷ Get Started Free |
| Viatris Specialty | PERFOROMIST | formoterol fumarate | SOLUTION;INHALATION | 022007-001 | May 11, 2007 | 7,348,362 | ⤷ Get Started Free |
| Viatris Specialty | PERFOROMIST | formoterol fumarate | SOLUTION;INHALATION | 022007-001 | May 11, 2007 | 6,814,953 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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