Details for New Drug Application (NDA): 216486
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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 216486
Tradename: | FORMOTEROL FUMARATE |
Applicant: | Ritedose Corp |
Ingredient: | formoterol fumarate |
Patents: | 0 |
Pharmacology for NDA: 216486
Mechanism of Action | Adrenergic beta2-Agonists |
Medical Subject Heading (MeSH) Categories for 216486
Suppliers and Packaging for NDA: 216486
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FORMOTEROL FUMARATE | formoterol fumarate | SOLUTION;INHALATION | 216486 | ANDA | Aucta Pharmaceuticals, Inc | 73289-0060 | 73289-0060-1 | 30 POUCH in 1 CARTON (73289-0060-1) / 2 mL in 1 POUCH (73289-0060-3) |
FORMOTEROL FUMARATE | formoterol fumarate | SOLUTION;INHALATION | 216486 | ANDA | Aucta Pharmaceuticals, Inc | 73289-0060 | 73289-0060-2 | 60 POUCH in 1 CARTON (73289-0060-2) / 2 mL in 1 POUCH (73289-0060-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 0.02MG/2ML | ||||
Approval Date: | Nov 25, 2022 | TE: | AN | RLD: | No |
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