FDA Orange Book · active-ingredient family
Methyldopa
Methyldopa: 3 brands, 43 generics; first approved Jun 29, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 43 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
43
Listed patents
0
Presentations
50
Brand (NDA) products
Originator applications
- ALDOMETRLDMERCKNDA 013400-3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - 500MG TABLET ORAL Discontinued - 125MG TABLET ORAL Discontinued - - METHYLDOPACHARTWELL RXNDA 01893419842 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - 500MG TABLET ORAL Discontinued - - MERCKNDA 018389-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML SUSPENSION ORAL Discontinued -
Generic (ANDA) products (43)
Abbreviated applications
- METHYLDOPASUPERPHARMANDA 0706691989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - - METHYLDOPASUPERPHARMANDA 0706701989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHYLDOPAPLIVAANDA 0721261988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Discontinued - - METHYLDOPAPLIVAANDA 0721271988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - - METHYLDOPAPLIVAANDA 0721281988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHYLDOPAHALSEYANDA 0717511988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Discontinued - - METHYLDOPAHALSEYANDA 0717521988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - - METHYLDOPAHALSEYANDA 0717531988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHYLDOPACHARTWELL RXANDA 0717001988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Discontinued - - METHYLDOPAQUAGENANDA 0705351987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Discontinued - - METHYLDOPAQUAGENANDA 0705361987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - - METHYLDOPAQUAGENANDA 0705371987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHYLDOPADURAMED PHARMS BARRANDA 0710061986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - - METHYLDOPADURAMED PHARMS BARRANDA 0710091986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHYLDOPATEVAANDA 0711051986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Discontinued - - METHYLDOPATEVAANDA 0711061986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - - METHYLDOPATEVAANDA 0710671986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHYLDOPASUN PHARM INDUSTRIESANDA 0700731986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Discontinued - - METHYLDOPASUN PHARM INDUSTRIESANDA 0700601986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - - METHYLDOPASUN PHARM INDUSTRIESANDA 0700741986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHYLDOPAWATSON LABSANDA 0707031986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - - METHYLDOPAWATSON LABSANDA 0706251986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHYLDOPAROXANEANDA 0701921986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Discontinued - - METHYLDOPAROXANEANDA 0701931986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - - METHYLDOPAROXANEANDA 0701941986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHYLDOPAPARKE DAVISANDA 0703311986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Discontinued - - METHYLDOPAPARKE DAVISANDA 0703321986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - - METHYLDOPAPARKE DAVISANDA 0703331986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHYLDOPAWATSON LABSANDA 0702451986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Discontinued - - METHYLDOPAWATSON LABSANDA 0702461986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - - METHYLDOPAWATSON LABSANDA 0702471986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHYLDOPAHERITAGE PHARMAANDA 0700981986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - - METHYLDOPAHERITAGE PHARMAANDA 0703431986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHYLDOPAPUREPAC PHARMANDA 0707491986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Discontinued - - METHYLDOPAPUREPAC PHARMANDA 0707501986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - - METHYLDOPAPUREPAC PHARMANDA 0704521986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHYLDOPAACCORD HLTHCAREANDA 0700701985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Discontinued - - METHYLDOPAACCORD HLTHCAREANDA 0700841985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - - METHYLDOPAACCORD HLTHCAREANDA 0700851985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHYLDOPAWATSON LABSANDA 0702601985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Discontinued - - METHYLDOPAWATSON LABSANDA 0702611985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued - - METHYLDOPAWATSON LABSANDA 0702621985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHYLDOPARISINGANDA 07007619852 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx - 250MG TABLET ORAL Rx -
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
42 yr 11 mo ago
Most recent approval
37 yr 11 mo ago
Approvals span 1984–1989 across 46 FDA applications.
Brand (NDA) 37%
Generic (ANDA) 4393%
Methyldopa: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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