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ALDOMET

NDA

METHYLDOPA | N013400 | MERCK RESEARCH LABORATORIES DIV MERCK CO INC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain4 active DMFs5 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

ZHEJIANG CHIRAL MEDICINE CHEMICALS CO LTDMETHYLDOPA

DMF 205652007

ZHEJIANG WILD WIND PHARMACEUTICAL CO LTDMETHYLDOPA (NON-STERILE, BULK FORM)

DMF 224252008

TAPI NL BVMETHYLDOPA

DMF 267262013

ZHEJIANG YONGTAI CHIRAL MEDICINE TECHNOLOGY CO LTDMETHYLDOPA

DMF 428292025

ANTIBIOTICOS SPAInactiveMETHYLDOPA USP

DMF 26961976

PLANTEX LTD CHEMICAL AND PHARMACEUTICAL WORKSInactiveMETHYLDOPA USP

DMF 32431978

ACIC LTDInactiveMETHYLDOPA USP

DMF 34721979

FARCHEMIA SRLInactiveMETHYLDOPA

DMF 61401985

DIVIS LABORATORIES LTDInactiveMETHYLDOPA USP

DMF 176992004

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 21, 2004	SUPPL -86	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#003 — 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982