Details for New Drug Application (NDA): 216128
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NDA 216128 describes ARFORMOTEROL TARTRATE, which is a drug marketed by Aiping Pharm Inc, Alembic, Cf Pharmtech, Cipla, Dr Reddys, Glenmark Pharms Ltd, Lupin, Mankind Pharma, Ritedose Corp, Slate Run Pharma, Sun Pharm, Teva Pharms Usa, and Wilshire Pharms Inc, and is included in thirteen NDAs. It is available from eleven 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. Eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the arformoterol tartrate profile page.
Summary for 216128
| Tradename: | ARFORMOTEROL TARTRATE |
| Applicant: | Mankind Pharma |
| Ingredient: | arformoterol tartrate |
| Patents: | 0 |
Pharmacology for NDA: 216128
| Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 216128
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARFORMOTEROL TARTRATE | arformoterol tartrate | SOLUTION;INHALATION | 216128 | ANDA | Lifestar Pharma LLC | 70756-612 | 70756-612-60 | 60 POUCH in 1 CARTON (70756-612-60) / 4 VIAL in 1 POUCH (70756-612-44) / 2 mL in 1 VIAL |
| ARFORMOTEROL TARTRATE | arformoterol tartrate | SOLUTION;INHALATION | 216128 | ANDA | Lifestar Pharma LLC | 70756-612 | 70756-612-70 | 30 POUCH in 1 CARTON (70756-612-70) / 1 VIAL in 1 POUCH (70756-612-12) / 2 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | EQ 0.015MG BASE/2ML | ||||
| Approval Date: | Nov 15, 2022 | TE: | AN | RLD: | No | ||||
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