Details for New Drug Application (NDA): 072755
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NDA 072755 describes LORAZEPAM INTENSOL, which is a drug marketed by Hikma and is included in one NDA. It is available from one supplier. Additional details are available on the LORAZEPAM INTENSOL profile page.
The generic ingredient in LORAZEPAM INTENSOL 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 LORAZEPAM INTENSOL 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.
Summary for 072755
| Tradename: | LORAZEPAM INTENSOL |
| Applicant: | Hikma |
| Ingredient: | lorazepam |
| Patents: | 0 |
Suppliers and Packaging for NDA: 072755
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LORAZEPAM INTENSOL | lorazepam | CONCENTRATE;ORAL | 072755 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-3532 | 0054-3532-44 | 1 BOTTLE in 1 CARTON (0054-3532-44) / 30 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CONCENTRATE;ORAL | Strength | 2MG/ML | ||||
| Approval Date: | Jun 28, 1991 | TE: | AA | RLD: | No | ||||
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