Details for New Drug Application (NDA): 215385
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NDA 215385 describes ARFORMOTEROL TARTRATE, which is a drug marketed by Aiping Pharm Inc, Alembic, Aucta, Be Pharms, Cf Pharmtech, Cipla, Dr Reddys, Glenmark Pharms Ltd, Lexenpharm, Lupin, Mankind Pharma, Micro Labs, Ritedose Corp, Sun Pharm, Teva Pharms Usa, and Wilshire Pharms Inc, and is included in sixteen NDAs. It is available from fourteen suppliers. Additional details are available on the ARFORMOTEROL TARTRATE profile page.
The generic ingredient in ARFORMOTEROL TARTRATE is arformoterol tartrate. There are four drug master file entries for this compound. Fourteen 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 are four drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the arformoterol tartrate profile page.
Summary for 215385
| Tradename: | ARFORMOTEROL TARTRATE |
| Applicant: | Sun Pharm |
| Ingredient: | arformoterol tartrate |
| Patents: | 0 |
Pharmacology for NDA: 215385
| Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 215385
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARFORMOTEROL TARTRATE | arformoterol tartrate | SOLUTION;INHALATION | 215385 | ANDA | American Health Packaging | 60687-770 | 60687-770-83 | 30 POUCH in 1 CARTON (60687-770-83) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE (60687-770-79) |
| ARFORMOTEROL TARTRATE | arformoterol tartrate | SOLUTION;INHALATION | 215385 | ANDA | American Health Packaging | 60687-770 | 60687-770-84 | 60 POUCH in 1 CARTON (60687-770-84) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE (60687-770-79) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | EQ 0.015MG BASE/2ML | ||||
| Approval Date: | May 26, 2022 | TE: | AN | RLD: | No | ||||
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