FDA — authorised 20 December 1962
- Status: approved
🇺🇸 Aldomet in United States
FDA authorised Aldomet on 20 December 1962
Marketing authorisations
FDA — authorised 20 December 1962
- Application: NDA013401
- Marketing authorisation holder: MERCK
- Local brand name: ALDOMET
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 December 1962
- Application: NDA013400
- Marketing authorisation holder: MERCK
- Local brand name: ALDOMET
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 August 1981
- Application: NDA018389
- Marketing authorisation holder: MERCK
- Local brand name: ALDOMET
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 29 June 1984
- Application: NDA018934
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 April 1985
- Application: ANDA070076
- Marketing authorisation holder: RISING
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 April 1985
- Application: ANDA070075
- Marketing authorisation holder: MYLAN
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 1985
- Application: ANDA070070
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 1985
- Application: ANDA070084
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 1985
- Application: ANDA070085
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 February 1986
- Application: ANDA070343
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 February 1986
- Application: ANDA070098
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 April 1986
- Application: ANDA070333
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 April 1986
- Application: ANDA070332
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 June 1986
- Application: ANDA070625
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 June 1986
- Application: ANDA070703
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 October 1986
- Application: ANDA070060
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 October 1986
- Application: ANDA070073
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 October 1986
- Application: ANDA070074
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 December 1986
- Application: ANDA071009
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 December 1986
- Application: ANDA071006
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 January 1987
- Application: ANDA070536
- Marketing authorisation holder: QUAGEN
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 January 1987
- Application: ANDA070537
- Marketing authorisation holder: QUAGEN
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 January 1987
- Application: ANDA070535
- Marketing authorisation holder: QUAGEN
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 March 1988
- Application: ANDA071700
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 July 1988
- Application: ANDA072128
- Marketing authorisation holder: PLIVA
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 July 1988
- Application: ANDA072127
- Marketing authorisation holder: PLIVA
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 July 1988
- Application: ANDA072126
- Marketing authorisation holder: PLIVA
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071067
- Marketing authorisation holder: TEVA
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070749
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070750
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070452
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071105
- Marketing authorisation holder: TEVA
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071106
- Marketing authorisation holder: TEVA
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070669
- Marketing authorisation holder: SUPERPHARM
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071751
- Marketing authorisation holder: HALSEY
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071753
- Marketing authorisation holder: HALSEY
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070193
- Marketing authorisation holder: ROXANE
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070192
- Marketing authorisation holder: ROXANE
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070670
- Marketing authorisation holder: SUPERPHARM
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071752
- Marketing authorisation holder: HALSEY
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070331
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070194
- Marketing authorisation holder: ROXANE
- Local brand name: METHYLDOPA
- Indication: TABLET — ORAL
- Status: approved
Aldomet in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Aldomet approved in United States?
Yes. FDA authorised it on 20 December 1962; FDA authorised it on 20 December 1962; FDA authorised it on 20 December 1962.
Who is the marketing authorisation holder for Aldomet in United States?
Marketing authorisation holder not available in our data.