Details for New Drug Application (NDA): 207537
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NDA 207537 describes METHADONE HYDROCHLORIDE, which is a drug marketed by Hikma, Lannett Co Inc, Specgx Llc, Vistapharm Llc, Long Grove Pharms, Mylan Institutional, Mallinckrodt Inc, Vistapharm, Ascent Pharms Inc, Aurolife Pharma Llc, Elite Labs Inc, Epic Pharma Llc, Roxane, Sun Pharm Industries, and Thepharmanetwork Llc, and is included in twenty-eight NDAs. It is available from seventeen suppliers. Additional details are available on the METHADONE HYDROCHLORIDE profile page.
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.
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 207537
| Tradename: | METHADONE HYDROCHLORIDE |
| Applicant: | Specgx Llc |
| Ingredient: | methadone hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 207537
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 207537
Suppliers and Packaging for NDA: 207537
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHADONE HYDROCHLORIDE | methadone hydrochloride | SOLUTION;ORAL | 207537 | ANDA | SpecGx LLC | 0406-6221 | 0406-6221-05 | 500 mL in 1 BOTTLE (0406-6221-05) |
| METHADONE HYDROCHLORIDE | methadone hydrochloride | SOLUTION;ORAL | 207537 | ANDA | SpecGx LLC | 0406-6225 | 0406-6225-05 | 500 mL in 1 BOTTLE (0406-6225-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
| Approval Date: | Oct 2, 2019 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 10MG/5ML | ||||
| Approval Date: | Oct 1, 2019 | TE: | AA | RLD: | No | ||||
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