Details for New Drug Application (NDA): 216426
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NDA 216426 describes FORMOTEROL FUMARATE, which is a drug marketed by Alembic, Deva Holding As, Dr Reddys, Lexenpharm, Lupin, Mankind Pharma, Micro Labs, Ritedose Corp, Teva Pharms Usa Inc, and Wilshire Pharms Inc, and is included in ten NDAs. It is available from thirteen suppliers. Additional details are available on the FORMOTEROL FUMARATE profile page.
The generic ingredient in FORMOTEROL FUMARATE is formoterol fumarate. There are nineteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the formoterol fumarate profile page.
The generic ingredient in FORMOTEROL FUMARATE is formoterol fumarate. There are nineteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the formoterol fumarate profile page.
Summary for 216426
| Tradename: | FORMOTEROL FUMARATE |
| Applicant: | Lexenpharm |
| Ingredient: | formoterol fumarate |
| Patents: | 0 |
Pharmacology for NDA: 216426
| Mechanism of Action | Adrenergic beta2-Agonists |
Medical Subject Heading (MeSH) Categories for 216426
Suppliers and Packaging for NDA: 216426
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FORMOTEROL FUMARATE | formoterol fumarate | SOLUTION;INHALATION | 216426 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-394 | 50742-394-30 | 30 POUCH in 1 CARTON (50742-394-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH (50742-394-01) / 2 mL in 1 VIAL, SINGLE-DOSE |
| FORMOTEROL FUMARATE | formoterol fumarate | SOLUTION;INHALATION | 216426 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-394 | 50742-394-60 | 60 POUCH in 1 CARTON (50742-394-60) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 0.02MG/2ML | ||||
| Approval Date: | Oct 22, 2024 | TE: | AN | RLD: | No | ||||
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