Details for New Drug Application (NDA): 208451
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NDA 208451 describes ESZOPICLONE, which is a drug marketed by Aurobindo Pharma, Chartwell Rx, Dr Reddys, Glenmark Pharms Ltd, Hetero Labs Ltd V, Hikma, Ipca Labs Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Nostrum Labs Inc, Orbion Pharms, Sun Pharm, and Teva, and is included in fourteen NDAs. It is available from thirty-three suppliers. Additional details are available on the ESZOPICLONE profile page.
The generic ingredient in ESZOPICLONE is eszopiclone. There are twenty drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the eszopiclone profile page.
The generic ingredient in ESZOPICLONE is eszopiclone. There are twenty drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the eszopiclone profile page.
Summary for 208451
| Tradename: | ESZOPICLONE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | eszopiclone |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 208451
Suppliers and Packaging for NDA: 208451
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESZOPICLONE | eszopiclone | TABLET;ORAL | 208451 | ANDA | A-S Medication Solutions | 50090-3514 | 50090-3514-0 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-3514-0) |
| ESZOPICLONE | eszopiclone | TABLET;ORAL | 208451 | ANDA | A-S Medication Solutions | 50090-4202 | 50090-4202-0 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-4202-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Sep 15, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Sep 15, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG | ||||
| Approval Date: | Sep 15, 2016 | TE: | AB | RLD: | No | ||||
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