Orange Book product · Brand (NDA)
ALDOMET
METHYLDOPATE HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
METHYLDOPATE HYDROCHLORIDE
Strength
50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 013401
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1991METHYLDOPATE HYDROCHLORIDEGeneric (ANDA)
ANDA 072974 · TEVA PARENTERAL
- 1987METHYLDOPATE HYDROCHLORIDEGeneric (ANDA)
ANDA 071812 · MARSAM PHARMS LLC
- 1987METHYLDOPATE HYDROCHLORIDEGeneric (ANDA)
ANDA 071279 · AM REGENT
- 1987METHYLDOPATE HYDROCHLORIDEGeneric (ANDA)
ANDA 070691 · HOSPIRA
- 1987METHYLDOPATE HYDROCHLORIDEGeneric (ANDA)
ANDA 070849 · HOSPIRA
- 1987METHYLDOPATE HYDROCHLORIDEGeneric (ANDA)
ANDA 070698 · HOSPIRA
- 1987METHYLDOPATE HYDROCHLORIDEGeneric (ANDA)
ANDA 070699 · HOSPIRA
- 1987METHYLDOPATE HYDROCHLORIDEGeneric (ANDA)
ANDA 070841 · SMITH AND NEPHEW
- 1986METHYLDOPATE HYDROCHLORIDEGeneric (ANDA)
ANDA 070291 · BAXTER HLTHCARE
- 1986METHYLDOPATE HYDROCHLORIDEGeneric (ANDA)
ANDA 070652 · ABRAXIS PHARM
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.
