FDA — authorised 10 April 1984
- Application: ANDA088357
- Marketing authorisation holder: IVAX PHARMS
- Local brand name: HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 GW642444M for 14 days in United States
FDA authorised GW642444M for 14 days on 10 April 1984
Marketing authorisations
FDA — authorised 10 April 1984
- Application: ANDA088358
- Marketing authorisation holder: IVAX PHARMS
- Local brand name: HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 July 1985
- Application: NDA019059
- Marketing authorisation holder: WYETH AYERST
- Local brand name: INDERIDE LA 120/50
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 December 1991
- Application: ANDA072723
- Marketing authorisation holder: WATSON LABS
- Local brand name: KELNOR 1/50
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 26 August 2008
- Application: BLA021810
- Marketing authorisation holder: NOVO NORDISK INC
- Local brand name: NOVOLOG MIX 50/50
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA
- Application: NDA016749
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: NORLESTRIN 21 1/50
- Indication: TABLET — ORAL-21
- Status: approved
FDA
- Application: NDA016852
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: NORLESTRIN 21 2.5/50
- Indication: TABLET — ORAL-21
- Status: approved
FDA
- Application: NDA016854
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: NORLESTRIN FE 2.5/50
- Indication: TABLET — ORAL-28
- Status: approved
FDA
- Application: NDA016723
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: NORLESTRIN 28 1/50
- Indication: TABLET — ORAL-28
- Status: approved
Frequently asked questions
Is GW642444M for 14 days approved in United States?
Yes. FDA authorised it on 10 April 1984; FDA authorised it on 10 April 1984; FDA authorised it on 3 July 1985.
Who is the marketing authorisation holder for GW642444M for 14 days in United States?
IVAX PHARMS holds the US marketing authorisation.