FDA Orange Book · active-ingredient family
Methyldopate hydrochloride
Methyldopate hydrochloride is approved as 1 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ALDOMET · NDA 013401
1
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ALDOMETRLD | MERCK | NDA 013401 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| METHYLDOPATE HYDROCHLORIDE | TEVA PARENTERAL | ANDA 072974 | — | Nov 22, 1991 | |
| METHYLDOPATE HYDROCHLORIDE | MARSAM PHARMS LLC | ANDA 071812 | — | Dec 22, 1987 | |
| METHYLDOPATE HYDROCHLORIDE | AM REGENT | ANDA 071279 | — | Oct 02, 1987 | |
| METHYLDOPATE HYDROCHLORIDE | HOSPIRA | ANDA 070691 | — | Jun 19, 1987 | |
| METHYLDOPATE HYDROCHLORIDE | HOSPIRA | ANDA 070849 | — | Jun 19, 1987 | |
| METHYLDOPATE HYDROCHLORIDE | HOSPIRA | ANDA 070698 | — | Jun 15, 1987 | |
| METHYLDOPATE HYDROCHLORIDE | HOSPIRA | ANDA 070699 | — | Jun 15, 1987 | |
| METHYLDOPATE HYDROCHLORIDE | SMITH AND NEPHEW | ANDA 070841 | — | Jan 02, 1987 | |
| METHYLDOPATE HYDROCHLORIDE | BAXTER HLTHCARE | ANDA 070291 | — | Jul 01, 1986 | |
| METHYLDOPATE HYDROCHLORIDE | ABRAXIS PHARM | ANDA 070652 | — | Jun 03, 1986 |
Listed patents
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.
Methyldopate hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
