Details for New Drug Application (NDA): 202768
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NDA 202768 describes ARMODAFINIL, which is a drug marketed by Aurobindo Pharma Ltd, Corepharma, Lupin Ltd, Mylan Pharms Inc, Natco Pharma Ltd, and Watson Labs Inc, and is included in six NDAs. It is available from seven suppliers. Additional details are available on the ARMODAFINIL profile page.
The generic ingredient in ARMODAFINIL is armodafinil. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the armodafinil profile page.
The generic ingredient in ARMODAFINIL is armodafinil. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the armodafinil profile page.
Summary for 202768
| Tradename: | ARMODAFINIL |
| Applicant: | Natco Pharma Ltd |
| Ingredient: | armodafinil |
| Patents: | 0 |
Suppliers and Packaging for NDA: 202768
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARMODAFINIL | armodafinil | TABLET;ORAL | 202768 | ANDA | Natco Pharma USA LLC | 69339-177 | 69339-177-03 | 30 TABLET in 1 BOTTLE (69339-177-03) |
| ARMODAFINIL | armodafinil | TABLET;ORAL | 202768 | ANDA | Natco Pharma USA LLC | 69339-177 | 69339-177-10 | 1000 TABLET in 1 BOTTLE (69339-177-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Nov 28, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Nov 28, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Nov 28, 2016 | TE: | AB | RLD: | No | ||||
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