FDA.reportPublic FDA data

Application 050420

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIFADINRIFAMPINCAPSULE;ORAL300MGYesYes
002RIFADINRIFAMPINCAPSULE;ORAL150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050420-001RIFADINRIFAMPIN300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982
N050420-002RIFADINRIFAMPIN150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 51 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050420-001RIFADIN300MGCAPSULE / ORALRLD, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050420-001RIFADIN300MGCAPSULE / ORALRLD, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050420-001RIFADIN300MGCAPSULE / ORALRLD, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N050420-001RIFADIN300MGCAPSULE / ORALRLD, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N050420-001RIFADIN300MGCAPSULE / ORALRLD, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050420-001RIFADIN300MGCAPSULE / ORALRLD, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N050420-001RIFADIN300MGCAPSULE / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050420-001RIFADIN300MGCAPSULE / ORALRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050420-001RIFADIN300MGCAPSULE / ORALRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050420-001RIFADIN300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050420-002RIFADIN150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N050420-001AB174a2ff9319b5…
2020-12-22 03:56 UTC2020-12N050420-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050420-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050420-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N050420-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N050420-001AB1ea99ee380514…

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 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RifadinRIFAMPICINSanofi-Aventis U.S. LLC1b074c23-dd35-43c9-820c-0e603481fdd32026-08-25Warnings, Adverse reactionsName fallback
brand name: Rifadin
RifampinRIFAMPINMylan Institutional LLC8be91604-d7cd-4f2b-997d-e3364e4092e52026-05-05Warnings, Adverse reactionsName fallback
generic name: RIFAMPIN
rifampinRIFAMPINBryant Ranch Prepack0cb75e95-d165-4580-9340-42d7a9fd546e2026-03-12Warnings, Adverse reactionsName fallback
generic name: RIFAMPIN
rifampinRIFAMPINMajor Pharmaceuticals3f3534c1-95e4-4bdd-b044-9026e4addf0c2026-02-27Warnings, Adverse reactionsName fallback
generic name: RIFAMPIN
rifampinRIFAMPINLupin Pharmaceuticals, Inc.b56004f0-f23d-47f6-80c7-39884fccbccc2026-02-11Warnings, Adverse reactionsName fallback
generic name: RIFAMPIN
rifampinRIFAMPINA-S Medication Solutionsd53b6998-6e3b-4c6f-8465-2af6897d1efe2026-01-05Warnings, Adverse reactionsName fallback
generic name: RIFAMPIN
RIFAMPINRIFAMPINCoupler LLC410a314f-83bf-d9b3-e063-6294a90a872c2025-10-13Warnings, Adverse reactionsName fallback
generic name: RIFAMPIN
RIFAMPINRIFAMPINPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS28109dee-3e5e-492b-b7d9-9ba46c0b53242025-03-25Warnings, Adverse reactionsName fallback
generic name: RIFAMPIN
RifampinRIFAMPINANI Pharmaceuticals, Inc.b389b1a3-672f-47e3-916c-4a9c044b211b2024-10-10Warnings, Adverse reactionsName fallback
generic name: RIFAMPIN
RIFAMPINRIFAMPINEPIC PHARMA, LLC0391f1e1-70d4-4b15-8b58-055bb6a385b82023-12-20Warnings, Adverse reactionsName fallback
generic name: RIFAMPIN
RifampinRIFAMPINChartwell RX, LLC4c39ee75-ae96-456d-bf47-16d49865345e2023-04-12Warnings, Adverse reactionsName fallback
generic name: RIFAMPIN
RifampinRIFAMPINFresenius Kabi USA, LLCa1f9f1e2-dfc0-4d31-a13b-b656d897b7912022-08-29Warnings, Adverse reactionsName fallback
generic name: RIFAMPIN
RifampinRIFAMPINHikma Pharmaceuticals USA Inc.cb59a48c-f66b-4ea0-809c-de0e4be2f8c22022-01-28Warnings, Adverse reactionsName fallback
generic name: RIFAMPIN

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 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0068-0508RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0508RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0508RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0508RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0508RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0508RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0508RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0508RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0510RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0510RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0510RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0510RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0510RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0510RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0510RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent
0068-0510RifadinrifampinSanofi-Aventis U.S. LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84407SUPPL 2025-12-15
84371SUPPL 2025-12-09
83706SUPPL 2025-10-09
83699SUPPL 2025-10-09
79872SUPPL 2024-10-11
79863SUPPL 2024-10-11
76766SUPPL 2023-12-12
76758SUPPL 2023-12-11
75121SUPPL 2023-08-18
75104SUPPL 2023-08-17
73581SUPPL 2023-02-21
73572SUPPL 2023-02-21
73495SUPPL 2023-02-14
73458SUPPL 2023-02-13
70049SUPPL2022-02-02
70000SUPPL2022-01-31
69077SUPPL2021-10-22
69066SUPPL2021-10-21
67872SUPPL2021-06-23
67860SUPPL2021-06-22
62952SUPPL2020-05-13
62950SUPPL2020-05-13
59864SUPPL2019-08-28
59858ORIG2019-08-28
57928SUPPL2019-03-07
57860SUPPL2019-03-01
57575SUPPL2019-02-13
57345SUPPL2019-01-25
51010SUPPL2018-01-10
51003SUPPL2018-01-09
48140SUPPL2017-04-27
48101SUPPL2017-04-25
38934SUPPL2013-03-01
7734SUPPL2013-03-01
30015SUPPL2010-11-22
17821SUPPL2010-11-12
38933SUPPL2004-08-25
30014SUPPL2004-08-25