Orange Book product · Brand (NDA)
NITHIODOTE
SODIUM NITRITE; SODIUM THIOSULFATE
At a glance
Jan 14, 2011
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 14, 2011
15 yr 8 mo ago
Today
Patent 11753301 expires
Listed drug substance patent expiration.
Feb 10, 2030
in 3 yr 8 mo
Patent 12304813 expires
Listed drug product patent expiration.
Feb 10, 2030
in 3 yr 8 mo
Patent 9687506 expires
Listed drug product patent expiration.
Feb 10, 2030
in 3 yr 8 mo
Patent 9687506 expires
Listed drug product patent expiration.
Feb 10, 2030
in 3 yr 8 mo
Patent 10479686 expires
Listed drug product patent expiration.
Jul 07, 2030
in 4 yr 1 mo
Patent 9345724 expires
Listed drug substance patent expiration.
Jul 07, 2030
in 4 yr 1 mo
Patent 9585912 expires
Listed drug substance patent expiration.
Jul 07, 2030
in 4 yr 1 mo
Patent 8496973 expires
Listed drug substance patent expiration.
Mar 29, 2031
in 4 yr 10 mo
Patent 8568793 expires
Listed drug substance patent expiration.
Dec 24, 2031
in 5 yr 7 mo
Pharmaceutical detail
Active ingredient
SODIUM NITRITE; SODIUM THIOSULFATE
Strength
300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)
Dosage form
SOLUTION, SOLUTION
Route
INTRAVENOUS, INTRAVENOUS
TE code
Not listed
Application
NDA 201444
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11753301 | Feb 10, 2030 | in 3 yr 8 mo | SubstanceProductU-3681 |
| 12304813 | Feb 10, 2030 | in 3 yr 8 mo | Product |
| 9687506 | Feb 10, 2030 | in 3 yr 8 mo | ProductU-3394 |
| 9687506 | Feb 10, 2030 | in 3 yr 8 mo | ProductU-3395 |
| 10479686 | Jul 07, 2030 | in 4 yr 1 mo | ProductU-3390 |
| 9345724 | Jul 07, 2030 | in 4 yr 1 mo | SubstanceProductU-2015 |
| 9585912 | Jul 07, 2030 | in 4 yr 1 mo | SubstanceProduct |
| 8496973 | Mar 29, 2031 | in 4 yr 10 mo | SubstanceProductU-1419 |
| 8568793 | Dec 24, 2031 | in 5 yr 7 mo | SubstanceProduct |

