Details for New Drug Application (NDA): 215883
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NDA 215883 describes FORMOTEROL FUMARATE, which is a drug marketed by Alembic, Lexenpharm, Lupin, Mankind Pharma, Micro Labs, Ritedose Corp, Teva Pharms Usa Inc, and Wilshire Pharms Inc, and is included in eight NDAs. It is available from eleven 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. Thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the formoterol fumarate profile page.
Summary for 215883
| Tradename: | FORMOTEROL FUMARATE |
| Applicant: | Mankind Pharma |
| Ingredient: | formoterol fumarate |
| Patents: | 0 |
Pharmacology for NDA: 215883
| Mechanism of Action | Adrenergic beta2-Agonists |
Medical Subject Heading (MeSH) Categories for 215883
Suppliers and Packaging for NDA: 215883
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FORMOTEROL FUMARATE | formoterol fumarate | SOLUTION;INHALATION | 215883 | ANDA | Major Pharmaceuticals | 0904-7454 | 0904-7454-11 | 30 POUCH in 1 CARTON (0904-7454-11) / 1 VIAL in 1 POUCH (0904-7454-98) / 2 mL in 1 VIAL |
| FORMOTEROL FUMARATE | formoterol fumarate | SOLUTION;INHALATION | 215883 | ANDA | Major Pharmaceuticals | 0904-7454 | 0904-7454-14 | 60 POUCH in 1 CARTON (0904-7454-14) / 4 VIAL in 1 POUCH (0904-7454-55) / 2 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 0.02MG/2ML | ||||
| Approval Date: | Mar 22, 2023 | TE: | AN | RLD: | No | ||||
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