Details for New Drug Application (NDA): 091113
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NDA 091113 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, Orbion Pharms, Pharmobedient, Sun Pharm, and Teva, and is included in fourteen NDAs. It is available from twenty-nine 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 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 suppliers are listed for this compound. Additional details are available on the eszopiclone profile page.
Summary for 091113
| Tradename: | ESZOPICLONE |
| Applicant: | Orbion Pharms |
| Ingredient: | eszopiclone |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 091113
Suppliers and Packaging for NDA: 091113
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESZOPICLONE | eszopiclone | TABLET;ORAL | 091113 | ANDA | Bionpharma Inc. | 69452-347 | 69452-347-13 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-347-13) |
| ESZOPICLONE | eszopiclone | TABLET;ORAL | 091113 | ANDA | Bionpharma Inc. | 69452-347 | 69452-347-20 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-347-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Jun 10, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Jun 10, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG | ||||
| Approval Date: | Jun 10, 2014 | TE: | AB | RLD: | No | ||||
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