Details for New Drug Application (NDA): 216486
✉ Email this page to a colleague
NDA 216486 describes FORMOTEROL FUMARATE, which is a drug marketed by Alembic, Lupin, Mankind Pharma, Micro Labs, Ritedose Corp, Teva Pharms Usa Inc, and Wilshire Pharms Inc, and is included in seven 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 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 | ||||
Complete Access Available with Subscription
