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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. 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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