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Details for New Drug Application (NDA): 070193

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NDA 070193 describes METHYLDOPA, which is a drug marketed by Sandoz, Watson Labs, Teva, Duramed Pharms Barr, Pliva, Parke Davis, Par Pharm, Ivax Sub Teva Pharms, Purepac Pharm, Halsey, Sun Pharm Inds, Superpharm, Accord Hlthcare, Mylan, Roxane, Dava Pharms Inc, Marsam Pharms Llc, Smith And Nephew, Hospira, Abraxis Pharm, Teva Parenteral, Luitpold, and Baxter Hlthcare, and is included in ninety-nine NDAs. It is available from ten suppliers. Additional details are available on the METHYLDOPA profile page.

The generic ingredient in METHYLDOPA is methyldopate hydrochloride. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the methyldopate hydrochloride profile page.

Summary for NDA: 070193

Therapeutic Class:Cardiovascular Agents

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength250MG
Approval Date:Apr 25, 1986TE:RLD:No

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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 verifification 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.