Details for New Drug Application (NDA): 017794
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NDA 017794 describes ATIVAN, which is a drug marketed by Hikma and Bausch and is included in two NDAs. It is available from three suppliers. Additional details are available on the ATIVAN profile page.
The generic ingredient in ATIVAN is lorazepam. There are eleven drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the lorazepam profile page.
The generic ingredient in ATIVAN is lorazepam. There are eleven drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the lorazepam profile page.
Suppliers and Packaging for NDA: 017794
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATIVAN | lorazepam | TABLET;ORAL | 017794 | NDA | Bausch Health US LLC | 0187-0063 | 0187-0063-01 | 100 TABLET in 1 BOTTLE (0187-0063-01) |
| ATIVAN | lorazepam | TABLET;ORAL | 017794 | NDA | Bausch Health US LLC | 0187-0064 | 0187-0064-01 | 100 TABLET in 1 BOTTLE (0187-0064-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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