Details for New Drug Application (NDA): 218304
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The generic ingredient in FORMOTEROL FUMARATE is formoterol fumarate. There are nineteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the formoterol fumarate profile page.
Summary for 218304
Tradename: | FORMOTEROL FUMARATE |
Applicant: | Micro Labs |
Ingredient: | formoterol fumarate |
Patents: | 0 |
Pharmacology for NDA: 218304
Mechanism of Action | Adrenergic beta2-Agonists |
Medical Subject Heading (MeSH) Categories for 218304
Suppliers and Packaging for NDA: 218304
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FORMOTEROL FUMARATE | formoterol fumarate | SOLUTION;INHALATION | 218304 | ANDA | Micro Labs Limited | 42571-463 | 42571-463-62 | 60 POUCH in 1 CARTON (42571-463-62) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL |
FORMOTEROL FUMARATE | formoterol fumarate | SOLUTION;INHALATION | 218304 | ANDA | Micro Labs Limited | 42571-463 | 42571-463-73 | 30 POUCH in 1 CARTON (42571-463-73) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 0.02MG/2ML | ||||
Approval Date: | Jun 26, 2024 | TE: | AN | RLD: | No |
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