Details for New Drug Application (NDA): 087393
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The generic ingredient in METHADONE HYDROCHLORIDE 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 087393
Tradename: | METHADONE HYDROCHLORIDE |
Applicant: | Hikma |
Ingredient: | methadone hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 087393
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 087393
Suppliers and Packaging for NDA: 087393
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHADONE HYDROCHLORIDE | methadone hydrochloride | SOLUTION;ORAL | 087393 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-3555 | 0054-3555-63 | 500 mL in 1 BOTTLE (0054-3555-63) |
METHADONE HYDROCHLORIDE | methadone hydrochloride | SOLUTION;ORAL | 087393 | ANDA | ATLANTIC BIOLOGICALS CORP. | 17856-3554 | 17856-3554-1 | 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-3554-1) / 5 mL in 1 SYRINGE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AA | RLD: | Yes |
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