INOMAX

020845 | Orange Book

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Filed Dec. 23, 1999
Type New Drug Application
Case Type New Drug Application
Ingredients NITRIC OXIDE
Dosage Form / Route GAS and INHALATION
PatentExpiration
11,931,3774 years, 1 month from now
8,282,9664 years, 2 months from now
8,293,2844 years, 2 months from now
8,431,1634 years, 2 months from now
8,795,7414 years, 2 months from now
8,846,1124 years, 2 months from now
11,931,3774 years, 7 months from now
8,282,9664 years, 8 months from now
8,293,2844 years, 8 months from now
8,431,1634 years, 8 months from now
8,795,7414 years, 8 months from now
8,846,1124 years, 8 months from now
8,291,9045 years, 8 months from now
8,573,2095 years, 8 months from now
8,573,2105 years, 8 months from now
8,776,7945 years, 8 months from now
8,776,7955 years, 8 months from now
9,265,9115 years, 8 months from now
9,295,8025 years, 8 months from now
9,408,9935 years, 8 months from now
8,291,9046 years, 2 months from now
8,573,2096 years, 2 months from now
8,573,2106 years, 2 months from now
8,776,7946 years, 2 months from now
8,776,7956 years, 2 months from now
9,265,9116 years, 2 months from now
9,295,8026 years, 2 months from now
9,408,9936 years, 2 months from now
9,279,7948 years, 10 months from now
9,279,7949 years, 4 months from now
9,770,57011 years from now
9,770,57011 years, 6 months from now
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Last Updated: 2 hours ago
Date Patent / Filing No. Patent and Drug Application Information
11/3/20369770570Expiration of Patent No 9,770,570: Has Pediatrict Exclusivity.
5/3/20369770570Expiration of Patent No 9,770,570: (U-2148).
8/19/20349279794Expiration of Patent No 9,279,794: Has Pediatrict Exclusivity.
2/19/20349279794Expiration of Patent No 9,279,794: (U-1823). (drug product)
7/6/20319408993Expiration of Patent No 9,408,993: Has Pediatrict Exclusivity.
7/6/20319295802Expiration of Patent No 9,295,802: Has Pediatrict Exclusivity.
7/6/20319265911Expiration of Patent No 9,265,911: Has Pediatrict Exclusivity.
7/6/20318776795Expiration of Patent No 8,776,795: Has Pediatrict Exclusivity.
7/6/20318776794Expiration of Patent No 8,776,794: Has Pediatrict Exclusivity.
7/6/20318573210Expiration of Patent No 8,573,210: Has Pediatrict Exclusivity.
7/6/20318573209Expiration of Patent No 8,573,209: Has Pediatrict Exclusivity.
7/6/20318291904Expiration of Patent No 8,291,904: Has Pediatrict Exclusivity.
1/6/20319408993Expiration of Patent No 9,408,993: (U-1824). (drug product)
1/6/20319295802Expiration of Patent No 9,295,802: (U-1226). (drug product)
1/6/20319265911Expiration of Patent No 9,265,911: (U-1824). (drug product)
1/6/20318776795Expiration of Patent No 8,776,795: (U-1226). (drug product)
1/6/20318776794Expiration of Patent No 8,776,794: (U-1226). (drug product)
1/6/20318573210Expiration of Patent No 8,573,210: (U-1453). (drug product)
1/6/20318573209Expiration of Patent No 8,573,209: (drug product)
1/6/20318291904Expiration of Patent No 8,291,904: (U-1226). (drug product)
12/30/20298846112Expiration of Patent No 8,846,112: Has Pediatrict Exclusivity.
12/30/20298795741Expiration of Patent No 8,795,741: Has Pediatrict Exclusivity.
12/30/20298431163Expiration of Patent No 8,431,163: Has Pediatrict Exclusivity.
12/30/20298293284Expiration of Patent No 8,293,284: Has Pediatrict Exclusivity.
12/30/20298282966Expiration of Patent No 8,282,966: Has Pediatrict Exclusivity.
12/3/202911931377Expiration of Patent No 11,931,377: Has Pediatrict Exclusivity.
6/30/20298846112Expiration of Patent No 8,846,112: (U-1286).
6/30/20298795741Expiration of Patent No 8,795,741: (U-1286).
6/30/20298431163Expiration of Patent No 8,431,163: (U-1286).
6/30/20298293284Expiration of Patent No 8,293,284: (U-1286).
6/30/20298282966Expiration of Patent No 8,282,966: (U-1286).
6/3/202911931377Expiration of Patent No 11,931,377: (U-3903). (drug product)
1/17/2023
Approval for INOMAX, 4880PPM
  • Reference Drug
  • Active Ingredient: NITRIC OXIDE
  • Dosage Form: GAS
  • Dosage Route: INHALATION
  • Therapeutic Equivalence:
1/17/2023SUPPL-21Manufacturing (CMC)-New Strength:
2/13/2019SUPPL-20Labeling-Package Insert:
4/5/2016SUPPL-18Labeling-Container/Carton Labels: Label is not available on this site.
10/9/2015SUPPL-17Efficacy-Labeling Change With Clinical Data:
10/9/2015SUPPL-16Labeling-Package Insert:
2/28/2014SUPPL-15Manufacturing (CMC): Label is not available on this site.
    3/4/2013SUPPL-14Labeling-Package Insert:
    12/21/2010SUPPL-11Efficacy-Labeling Change With Clinical Data:
    8/26/2009SUPPL-9Labeling:
    12/4/2007SUPPL-4Labeling: Label is not available on this site.
    6/15/2004SUPPL-2Labeling: Label is not available on this site.
    5/21/2001SUPPL-1Labeling: Label is not available on this site.
      12/23/1999
      Approval for INOMAX, 800PPM
      • Reference Drug
      • Active Ingredient: NITRIC OXIDE
      • Dosage Form: GAS
      • Dosage Route: INHALATION
      • Therapeutic Equivalence: Products in conventional dosage forms not presenting bioequivalence problems
      12/23/1999
      Approval for INOMAX, 100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
      • Reference Drug
      • Active Ingredient: NITRIC OXIDE
      • Dosage Form: GAS
      • Dosage Route: INHALATION
      • Therapeutic Equivalence:
      12/23/1999ORIG-1Approval: