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ROPINIROLE

 
 
Content specific to this active ingredient…

Drug Information
Prescribing and patient information from leading authorities

Drug Master Files
Type 2 master files on file at the FDA

Drug Recalls
For prescription drugs containing this active ingredient

Exclusivity
Patent and market exclusivity data

Federal Register
FR search results for this API

FDA Approved Labelling
Information found in this drug's package inserts

Research Links
Chemical identification and research citations

Title 21 Code of Federal Regulations
FDA regulations for this API

   

 


 

FDA Approval Activities for this Drug…

Requip (ropinirole hydrochloride) Tablets, GlaxoSmithKline NDA 20-658 / S012 | REQUIP (ropinirole hydrochloride) Tablets, SmithKline Beecham, New or Modified Indication | Ropinirole Hydrochloride Tablets, Roxane Labs, Tentative Approval | Ropinirole Hydrochloride Tablets, Par Pharma, Tentative Approval | Ropinirole Hydrochloride Tablets, Par Pharma, Tentative Approval | Ropinirole Hydrochloride Tablets, Teva Pharma, Tentative Approval | Ropinirole Hydrochloride Tablets, Mylan Pharmaceuticals Inc., Approval | Ropinirole Hydrochloride Tablets, Teva Pharmaceuticals, Approval | Ropinirole Hydrochloride Tablets, Roxane Laboratories, Inc., Approval | Ropinirole Hydrochloride Tablets, Par Pharmaceutical, Inc., Approval | Ropinirole Hydrochloride Tablets, Corepharma, LLC, Approval | Ropinirole Hydrochloride Tablets, Wockhardt USA, Inc., Approval | Requip XL (ropinirole) Extended-Release Tablets, GlaxoSmithKline, Approval | Requip XL (ropinirole) Extended-Release Tablets, GlaxoSmithKline, Approval | Requip XL (ropinirole hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Formulation Revision

^ FDA's latest approval appears at the bottom of this list. ^


 

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