Details for New Drug Application (NDA): 017116
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NDA 017116 describes METHADOSE, which is a drug marketed by Specgx Llc and is included in three NDAs. It is available from one supplier. Additional details are available on the METHADOSE profile page.
The generic ingredient in METHADOSE is methadone hydrochloride. There are thirteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.
The generic ingredient in METHADOSE is methadone hydrochloride. There are thirteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.
Summary for 017116
| Tradename: | METHADOSE |
| Applicant: | Specgx Llc |
| Ingredient: | methadone hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 017116
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 017116
Suppliers and Packaging for NDA: 017116
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHADOSE | methadone hydrochloride | CONCENTRATE;ORAL | 017116 | NDA | SpecGx LLC | 0406-0527 | 0406-0527-10 | 1000 mL in 1 BOTTLE, PLASTIC (0406-0527-10) |
| METHADOSE | methadone hydrochloride | CONCENTRATE;ORAL | 017116 | NDA | SpecGx LLC | 0406-8725 | 0406-8725-10 | 1000 mL in 1 BOTTLE, PLASTIC (0406-8725-10) |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CONCENTRATE;ORAL | Strength | 10MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AA | RLD: | Yes | ||||
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