Details for New Drug Application (NDA): 218380
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NDA 218380 describes ARFORMOTEROL TARTRATE, which is a drug marketed by Aiping Pharm Inc, Alembic, Aucta, Cipla, Dr Reddys, Glenmark Pharms Ltd, Lexenpharm, Lupin, Mankind Pharma, Micro Labs, Neocubes Pharma, Ritedose Corp, Saba Ilac Sanayi, Slate Run Pharma, Sun Pharm, Teva Pharms Usa, and Wilshire Pharms Inc, and is included in seventeen NDAs. It is available from fifteen suppliers. Additional details are available on the ARFORMOTEROL TARTRATE profile page.
The generic ingredient in ARFORMOTEROL TARTRATE is arformoterol tartrate. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the arformoterol tartrate profile page.
The generic ingredient in ARFORMOTEROL TARTRATE is arformoterol tartrate. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the arformoterol tartrate profile page.
Summary for 218380
| Tradename: | ARFORMOTEROL TARTRATE |
| Applicant: | Aucta |
| Ingredient: | arformoterol tartrate |
| Patents: | 0 |
Pharmacology for NDA: 218380
| Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 218380
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARFORMOTEROL TARTRATE | arformoterol tartrate | SOLUTION;INHALATION | 218380 | ANDA | Aucta Pharmaceuticals, Inc. | 73289-0072 | 73289-0072-3 | 30 POUCH in 1 CARTON (73289-0072-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (73289-0072-1) / 2 mL in 1 VIAL, SINGLE-DOSE |
| ARFORMOTEROL TARTRATE | arformoterol tartrate | SOLUTION;INHALATION | 218380 | ANDA | Aucta Pharmaceuticals, Inc. | 73289-0072 | 73289-0072-4 | 15 POUCH in 1 CARTON (73289-0072-4) / 4 VIAL, SINGLE-DOSE in 1 POUCH (73289-0072-2) / 2 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | EQ 0.015MG BASE/2ML | ||||
| Approval Date: | Feb 3, 2025 | TE: | AN | RLD: | No | ||||
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