Details for New Drug Application (NDA): 071415
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NDA 071415 describes DIAZEPAM 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 DIAZEPAM INTENSOL profile page.
The generic ingredient in DIAZEPAM INTENSOL is diazepam. There are eight drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the diazepam profile page.
The generic ingredient in DIAZEPAM INTENSOL is diazepam. There are eight drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the diazepam profile page.
Summary for 071415
| Tradename: | DIAZEPAM INTENSOL |
| Applicant: | Hikma |
| Ingredient: | diazepam |
| Patents: | 0 |
Suppliers and Packaging for NDA: 071415
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIAZEPAM INTENSOL | diazepam | CONCENTRATE;ORAL | 071415 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-3185 | 0054-3185-44 | 1 BOTTLE in 1 CARTON (0054-3185-44) / 30 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CONCENTRATE;ORAL | Strength | 5MG/ML | ||||
| Approval Date: | Apr 3, 1987 | TE: | AA | RLD: | No | ||||
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