FDA — authorised 16 January 1968
- Application: NDA016192
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: SORBITRATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Standard of Care IV antihypertensive in United States
FDA authorised Standard of Care IV antihypertensive on 16 January 1968
Marketing authorisations
FDA — authorised 7 December 1970
- Application: NDA016776
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: SORBITRATE
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 1 December 1978
- Application: ANDA084204
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 2 March 1982
- Application: ANDA086166
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 March 1982
- Application: ANDA086055
- Marketing authorisation holder: HIKMA INTL PHARMS
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 28 April 1982
- Application: ANDA086221
- Marketing authorisation holder: SANDOZ
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 June 1982
- Application: ANDA086223
- Marketing authorisation holder: SANDOZ
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 June 1982
- Application: ANDA086222
- Marketing authorisation holder: SANDOZ
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 20 July 1982
- Application: ANDA086032
- Marketing authorisation holder: ANI PHARMS
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 July 1982
- Application: ANDA086167
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 September 1982
- Application: ANDA087537
- Marketing authorisation holder: PH HEALTH
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 September 1982
- Application: ANDA086925
- Marketing authorisation holder: PH HEALTH
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 April 1983
- Application: ANDA086225
- Marketing authorisation holder: SANDOZ
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 21 November 1983
- Application: ANDA086169
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 November 1983
- Application: ANDA086923
- Marketing authorisation holder: PH HEALTH
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 May 1984
- Application: ANDA088088
- Marketing authorisation holder: HIKMA INTL PHARMS
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 July 1984
- Application: ANDA087545
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 13 July 1984
- Application: ANDA087564
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 December 1984
- Application: ANDA087946
- Marketing authorisation holder: PH HEALTH
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 February 1985
- Application: ANDA086034
- Marketing authorisation holder: WATSON LABS
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 February 1985
- Application: ANDA086031
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 25 February 1985
- Application: ANDA086033
- Marketing authorisation holder: WATSON LABS
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 17 February 1987
- Application: ANDA089190
- Marketing authorisation holder: SUPERPHARM
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 February 1987
- Application: ANDA089192
- Marketing authorisation holder: SUPERPHARM
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 February 1987
- Application: ANDA089191
- Marketing authorisation holder: SUPERPHARM
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 April 1988
- Application: ANDA089367
- Marketing authorisation holder: SANDOZ
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 September 1988
- Application: NDA019790
- Marketing authorisation holder: ENDO OPERATIONS
- Local brand name: DILATRATE-SR
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 1 December 1998
- Application: ANDA086168
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 30 December 1998
- Application: ANDA040009
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 January 2007
- Application: ANDA040591
- Marketing authorisation holder: HIKMA INTL PHARMS
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 March 2008
- Application: ANDA040723
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 8 July 2022
- Application: ANDA215723
- Marketing authorisation holder: RUBICON
- Local brand name: ISOSORBIDE DINITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA016191
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: SORBITRATE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA
- Application: ANDA088124
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: SORBITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086405
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: SORBITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088125
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: SORBITRATE
- Indication: TABLET — ORAL
- Status: approved
Other Cardiovascular approved in United States
Frequently asked questions
Is Standard of Care IV antihypertensive approved in United States?
Yes. FDA authorised it on 16 January 1968; FDA authorised it on 7 December 1970; FDA authorised it on 1 December 1978.
Who is the marketing authorisation holder for Standard of Care IV antihypertensive in United States?
ASTRAZENECA holds the US marketing authorisation.