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Details for New Drug Application (NDA): 074184
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NDA 074184 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. Twenty-two 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. Twenty-two suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.
Summary for 074184
| Tradename: | METHADOSE |
| Applicant: | Specgx Llc |
| Ingredient: | methadone hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074184
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 074184
Suppliers and Packaging for NDA: 074184
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHADOSE | methadone hydrochloride | TABLET, FOR SUSPENSION;ORAL | 074184 | ANDA | SpecGx LLC | 0406-0540 | 0406-0540-34 | 100 TABLET in 1 BOTTLE (0406-0540-34) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 40MG | ||||
| Approval Date: | Apr 29, 1993 | TE: | AA | RLD: | No | ||||
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