Application 205766

Type
NDA
Sponsor
LINDE NORTH AMERICA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITROGEN, NFNITROGENGAS;INHALATIONN/ANoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NITROGENNITROGENAirweld, Inc55e1aa68-e3e4-4862-a16c-18bcaed5be182024-10-08Exact identifier
application applno (NDA): 205766
application number: NDA205766
NITROGENNITROGENNoble Gas Solutions, Inc.af2bcc03-89aa-48aa-8749-cb53be56432e2024-10-06Exact identifier
application applno (NDA): 205766
application number: NDA205766
ndc (product): 17819-1066
NITROGENNITROGENADF Welding & Medical, Inc.174cb8ea-66fb-4d0b-920f-01fba9537ee92024-10-02Exact identifier
application applno (NDA): 205766
application number: NDA205766

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 3 · 224 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10218-102NITROGENNITROGENCEE-KAY SUPPLY, INC.NDACurrent
10218-102NITROGENNITROGENCEE-KAY SUPPLY, INC.NDACurrent
10218-102NITROGENNITROGENCEE-KAY SUPPLY, INC.NDACurrent
10218-102NITROGENNITROGENCEE-KAY SUPPLY, INC.NDACurrent
10218-102NITROGENNITROGENCEE-KAY SUPPLY, INC.NDACurrent
10297-200NitrogenNitrogenA OX Welding Supply Company Inc.NDACurrent
10297-200NitrogenNitrogenA OX Welding Supply Company Inc.NDACurrent
10526-003NitrogenNitrogenHaun Welding Supply, Inc.NDACurrent
10526-006NitrogenNitrogenHaun Welding Supply, Inc.NDACurrent
10526-006NitrogenNitrogenHaun Welding Supply, Inc.NDACurrent
10526-006NitrogenNitrogenHaun Welding Supply, Inc.NDACurrent
10526-006NitrogenNitrogenHaun Welding Supply, Inc.NDACurrent
10526-006NitrogenNitrogenHaun Welding Supply, Inc.NDACurrent
10927-101NITROGENNITROGENPURITY CYLINDER GASES INCNDACurrent
10927-106NITROGENNITROGENPURITY CYLINDER GASES INCNDACurrent
11043-002NitrogenNitrogenS. J. Smith Co., Inc.NDACurrent
11043-002NitrogenNitrogenS. J. Smith Co., Inc.NDACurrent
11043-002NitrogenNitrogenS. J. Smith Co., Inc.NDACurrent
11043-002NitrogenNitrogenS. J. Smith Co., Inc.NDACurrent
11043-002NitrogenNitrogenS. J. Smith Co., Inc.NDACurrent
11999-002NITROGENNITROGENWelders Supply CompanyNDACurrent
11999-002NITROGENNITROGENWelders Supply CompanyNDACurrent
11999-002NITROGENNITROGENWelders Supply CompanyNDACurrent
11999-002NITROGENNITROGENWelders Supply CompanyNDACurrent
11999-002NITROGENNITROGENWelders Supply CompanyNDACurrent
11999-002NITROGENNITROGENWelders Supply CompanyNDACurrent
12121-006NITROGENNITROGENBadger Welding Supplies, IncNDACurrent
12121-006NITROGENNITROGENBadger Welding Supplies, IncNDACurrent
12121-006NITROGENNITROGENBadger Welding Supplies, IncNDACurrent
12121-006NITROGENNITROGENBadger Welding Supplies, IncNDACurrent
12121-006NITROGENNITROGENBadger Welding Supplies, IncNDACurrent
12121-006NITROGENNITROGENBadger Welding Supplies, IncNDACurrent
14208-003NITROGENNITROGENCalifornia Tool & Welding Supply, LLCNDACurrent
14208-003NITROGENNITROGENCalifornia Tool & Welding Supply, LLCNDACurrent
14208-003NITROGENNITROGENCalifornia Tool & Welding Supply, LLCNDACurrent
14208-003NITROGENNITROGENCalifornia Tool & Welding Supply, LLCNDACurrent
14208-003NITROGENNITROGENCalifornia Tool & Welding Supply, LLCNDACurrent
14961-003NitrogenNitrogenHaun Specialty Gases, Inc.NDACurrent
14961-007NitrogenNitrogenHaun Specialty Gases, Inc.NDACurrent
14961-007NitrogenNitrogenHaun Specialty Gases, Inc.NDACurrent
14961-007NitrogenNitrogenHaun Specialty Gases, Inc.NDACurrent
14961-007NitrogenNitrogenHaun Specialty Gases, Inc.NDACurrent
15687-001NitrogenNitrogenBig Branch Breeders ServiceNDACurrent
15687-001NitrogenNitrogenBig Branch Breeders ServiceNDACurrent
15687-001NitrogenNitrogenBig Branch Breeders ServiceNDACurrent
15687-001NitrogenNitrogenBig Branch Breeders ServiceNDACurrent
15687-001NitrogenNitrogenBig Branch Breeders ServiceNDACurrent
17575-006NitrogenNitrogenAGL Inhalation Therapy Co.NDACurrent
17575-006NitrogenNitrogenAGL Inhalation Therapy Co.NDACurrent
17575-006NitrogenNitrogenAGL Inhalation Therapy Co.NDACurrent
17575-006NitrogenNitrogenAGL Inhalation Therapy Co.NDACurrent
17575-006NitrogenNitrogenAGL Inhalation Therapy Co.NDACurrent
17819-1066NITROGENNITROGENNoble Gas Solutions, Inc.NDACurrent
17819-1066NITROGENNITROGENNoble Gas Solutions, Inc.NDACurrent
17819-1066NITROGENNITROGENNoble Gas Solutions, Inc.NDACurrent
17819-1066NITROGENNITROGENNoble Gas Solutions, Inc.NDACurrent
33335-002NitrogenNitrogenWELSCO, INC.NDACurrent
33335-002NitrogenNitrogenWELSCO, INC.NDACurrent
33335-002NitrogenNitrogenWELSCO, INC.NDACurrent
33335-002NitrogenNitrogenWELSCO, INC.NDACurrent
33335-002NitrogenNitrogenWELSCO, INC.NDACurrent
33335-002NitrogenNitrogenWELSCO, INC.NDACurrent
42068-002NitrogenNitrogenJackson Welding Supply Co Inc.NDACurrent
42068-002NitrogenNitrogenJackson Welding Supply Co Inc.NDACurrent
42068-002NitrogenNitrogenJackson Welding Supply Co Inc.NDACurrent
42068-002NitrogenNitrogenJackson Welding Supply Co Inc.NDACurrent
42068-002NitrogenNitrogenJackson Welding Supply Co Inc.NDACurrent
42241-002NitrogenNitrogenINDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC.NDACurrent
42241-002NitrogenNitrogenINDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC.NDACurrent
42241-002NitrogenNitrogenINDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC.NDACurrent
42241-002NitrogenNitrogenINDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC.NDACurrent
42241-002NitrogenNitrogenINDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC.NDACurrent
42241-002NitrogenNitrogenINDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC.NDACurrent
47632-0003NITROGENNITROGENO.E. Meyer CompanyNDACurrent
47632-0003NITROGENNITROGENO.E. Meyer CompanyNDACurrent
47632-0003NITROGENNITROGENO.E. Meyer CompanyNDACurrent
47632-0003NITROGENNITROGENO.E. Meyer CompanyNDACurrent
47632-0003NITROGENNITROGENO.E. Meyer CompanyNDACurrent
47632-0003NITROGENNITROGENO.E. Meyer CompanyNDACurrent
48273-006NITROGENNITROGENKeen Compressed Gas Co. Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10497ORIG2015-10-02