You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Details for New Drug Application (NDA): 208193


✉ Email this page to a colleague

« Back to Dashboard


NDA 208193 describes OZOBAX DS, which is a drug marketed by Metacel Pharms Llc and is included in one NDA. It is available from four suppliers. Additional details are available on the OZOBAX DS profile page.

The generic ingredient in OZOBAX DS is baclofen. There are twenty-one drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the baclofen profile page.
Summary for 208193
Tradename:OZOBAX DS
Applicant:Metacel Pharms Llc
Ingredient:baclofen
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 208193
Mechanism of ActionGABA A Agonists
GABA B Agonists
Medical Subject Heading (MeSH) Categories for 208193
Suppliers and Packaging for NDA: 208193
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OZOBAX baclofen SOLUTION;ORAL 208193 NDA AUTHORIZED GENERIC TRUPHARMA, LLC 52817-620 52817-620-08 237 mL in 1 BOTTLE (52817-620-08)
OZOBAX baclofen SOLUTION;ORAL 208193 NDA AUTHORIZED GENERIC Palmetto Pharmaceuticals Inc. 68134-401 68134-401-16 473 mL in 1 BOTTLE (68134-401-16)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength5MG/5ML
Approval Date:Sep 18, 2019TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Aug 30, 2039Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF SPASTICITY

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10MG/5ML
Approval Date:Oct 12, 2023TE:RLD:Yes

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.