FDA Orange Book · active-ingredient family
Methyldopate hydrochloride
Methyldopate hydrochloride: 1 brand, 10 generics; first approved Jun 03, 1986; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 10 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
10
Listed patents
0
Presentations
11
Brand (NDA) products
Originator applications
- ALDOMETRLDMERCKNDA 013401—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (10)
Abbreviated applications
- METHYLDOPATE HYDROCHLORIDETEVA PARENTERALANDA 0729741991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - METHYLDOPATE HYDROCHLORIDEMARSAM PHARMS LLCANDA 0718121987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - METHYLDOPATE HYDROCHLORIDEAM REGENTANDA 0712791987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - METHYLDOPATE HYDROCHLORIDEHOSPIRAANDA 0706911987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - METHYLDOPATE HYDROCHLORIDEHOSPIRAANDA 0708491987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - METHYLDOPATE HYDROCHLORIDEHOSPIRAANDA 0706981987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - METHYLDOPATE HYDROCHLORIDEHOSPIRAANDA 0706991987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - METHYLDOPATE HYDROCHLORIDESMITH AND NEPHEWANDA 0708411987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - METHYLDOPATE HYDROCHLORIDEBAXTER HLTHCAREANDA 0702911986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - METHYLDOPATE HYDROCHLORIDEABRAXIS PHARMANDA 0706521986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued —
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
40 yr 11 mo ago
Most recent approval
35 yr 5 mo ago
Approvals span 1986–1991 across 11 FDA applications.
Brand (NDA) 19%
Generic (ANDA) 1091%
Methyldopate hydrochloride: 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.
