Details for New Drug Application (NDA): 215621
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The generic ingredient in FORMOTEROL FUMARATE is formoterol fumarate. There are nineteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the formoterol fumarate profile page.
Summary for 215621
Tradename: | FORMOTEROL FUMARATE |
Applicant: | Wilshire Pharms Inc |
Ingredient: | formoterol fumarate |
Patents: | 0 |
Pharmacology for NDA: 215621
Mechanism of Action | Adrenergic beta2-Agonists |
Medical Subject Heading (MeSH) Categories for 215621
Suppliers and Packaging for NDA: 215621
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FORMOTEROL FUMARATE | formoterol fumarate | SOLUTION;INHALATION | 215621 | ANDA | Rhodes Pharmaceuticals L.P. | 42858-094 | 42858-094-35 | 30 POUCH in 1 CARTON (42858-094-35) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL |
FORMOTEROL FUMARATE | formoterol fumarate | SOLUTION;INHALATION | 215621 | ANDA | Rhodes Pharmaceuticals L.P. | 42858-094 | 42858-094-62 | 60 POUCH in 1 CARTON (42858-094-62) / 1 VIAL in 1 POUCH (42858-094-21) / 2 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 0.02MG/2ML | ||||
Approval Date: | Dec 13, 2022 | TE: | AN | RLD: | No |
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