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Last Updated: April 18, 2024

Methyldopate hydrochloride - Generic Drug Details


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What are the generic drug sources for methyldopate hydrochloride and what is the scope of freedom to operate?

Methyldopate hydrochloride is the generic ingredient in two branded drugs marketed by Merck, Abraxis Pharm, Am Regent, Baxter Hlthcare, Hospira, Marsam Pharms Llc, Smith And Nephew, and Teva Parenteral, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for methyldopate hydrochloride.

Summary for methyldopate hydrochloride

US Patents and Regulatory Information for methyldopate hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira METHYLDOPATE HYDROCHLORIDE methyldopate hydrochloride INJECTABLE;INJECTION 070849-001 Jun 19, 1987 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck ALDOMET methyldopate hydrochloride INJECTABLE;INJECTION 013401-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira METHYLDOPATE HYDROCHLORIDE methyldopate hydrochloride INJECTABLE;INJECTION 070699-001 Jun 15, 1987 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Marsam Pharms Llc METHYLDOPATE HYDROCHLORIDE methyldopate hydrochloride INJECTABLE;INJECTION 071812-001 Dec 22, 1987 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Smith And Nephew METHYLDOPATE HYDROCHLORIDE methyldopate hydrochloride INJECTABLE;INJECTION 070841-001 Jan 2, 1987 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira METHYLDOPATE HYDROCHLORIDE methyldopate hydrochloride INJECTABLE;INJECTION 070698-001 Jun 15, 1987 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abraxis Pharm METHYLDOPATE HYDROCHLORIDE methyldopate hydrochloride INJECTABLE;INJECTION 070652-001 Jun 3, 1986 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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