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Generated: January 19, 2019

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Details for New Drug Application (NDA): 006134

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NDA 006134 describes DOLOPHINE HYDROCHLORIDE, which is a drug marketed by West-ward Pharms Int and is included in one NDA. It is available from four suppliers. 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. Twenty-two suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.
Summary for 006134
Tradename:DOLOPHINE HYDROCHLORIDE
Applicant:West-ward Pharms Int
Ingredient:methadone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 006134
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 006134
Suppliers and Packaging for NDA: 006134
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOLOPHINE HYDROCHLORIDE methadone hydrochloride SYRUP;ORAL 006134 NDA West-Ward Pharmaceuticals Corp. 0054-4218 0054-4218-25 100 TABLET in 1 BOTTLE, PLASTIC (0054-4218-25)
DOLOPHINE HYDROCHLORIDE methadone hydrochloride SYRUP;ORAL 006134 NDA West-Ward Pharmaceuticals Corp. 0054-4219 0054-4219-25 100 TABLET in 1 BOTTLE, PLASTIC (0054-4219-25)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:SYRUP;ORALStrength10MG/30ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 010

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:Yes

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