Details for New Drug Application (NDA): 074184
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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 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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