Details for New Drug Application (NDA): 089897
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NDA 089897 describes METHADONE HYDROCHLORIDE INTENSOL, which is a drug marketed by Hikma and is included in one NDA. It is available from two suppliers. Additional details are available on the METHADONE HYDROCHLORIDE INTENSOL profile page.
The generic ingredient in METHADONE HYDROCHLORIDE INTENSOL is methadone hydrochloride. There are thirteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.
The generic ingredient in METHADONE HYDROCHLORIDE INTENSOL is methadone hydrochloride. There are thirteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.
Summary for 089897
| Tradename: | METHADONE HYDROCHLORIDE INTENSOL |
| Applicant: | Hikma |
| Ingredient: | methadone hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 089897
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 089897
Suppliers and Packaging for NDA: 089897
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHADONE HYDROCHLORIDE INTENSOL | methadone hydrochloride | CONCENTRATE;ORAL | 089897 | ANDA | Hikma Pharmaceuticals USA | 0054-0391 | 0054-0391-68 | 1000 mL in 1 BOTTLE (0054-0391-68) |
| METHADONE HYDROCHLORIDE INTENSOL | methadone hydrochloride | CONCENTRATE;ORAL | 089897 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-3553 | 0054-3553-44 | 30 mL in 1 BOTTLE, DROPPER (0054-3553-44) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CONCENTRATE;ORAL | Strength | 10MG/ML | ||||
| Approval Date: | Sep 6, 1988 | TE: | AA | RLD: | No | ||||
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