Details for New Drug Application (NDA): 215053
NDA 215053 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 eleven suppliers. Additional details are available on the FORMOTEROL FUMARATE profile page.
The generic ingredient in FORMOTEROL FUMARATE is formoterol fumarate. There is one drug master file entry 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 is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the formoterol fumarate profile page.
Summary for 215053
| Tradename: | FORMOTEROL FUMARATE |
| Applicant: | Lupin |
| Ingredient: | formoterol fumarate |
| Patents: | 0 |
Pharmacology for NDA: 215053
| Mechanism of Action | Adrenergic beta2-Agonists |
Medical Subject Heading (MeSH) Categories for 215053
Suppliers and Packaging for NDA: 215053
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FORMOTEROL FUMARATE | formoterol fumarate | SOLUTION;INHALATION | 215053 | ANDA | Lupin Pharmaceuticals, Inc. | 70748-261 | 70748-261-30 | 30 POUCH in 1 CARTON (70748-261-30) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL |
| FORMOTEROL FUMARATE | formoterol fumarate | SOLUTION;INHALATION | 215053 | ANDA | Lupin Pharmaceuticals, Inc. | 70748-261 | 70748-261-60 | 60 POUCH in 1 CARTON (70748-261-60) / 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: | Aug 22, 2022 | TE: | AN | RLD: | No | ||||
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