Details for New Drug Application (NDA): 006134
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NDA 006134 describes DOLOPHINE HYDROCHLORIDE, which is a drug marketed by Hikma and is included in one NDA. Additional details are available on the DOLOPHINE HYDROCHLORIDE profile page.
The generic ingredient in DOLOPHINE 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 DOLOPHINE 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 006134
| Tradename: | DOLOPHINE HYDROCHLORIDE |
| Applicant: | Hikma |
| Ingredient: | methadone hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 006134
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SYRUP;ORAL | Strength | 10MG/30ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 010
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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