FDA.reportPublic FDA data

Application 090033

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIFABUTINRIFABUTINCAPSULE;ORAL150MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090033-001RIFABUTINRIFABUTIN150MGCAPSULE / ORAL2014-02-24

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090033-001RIFABUTIN150MGCAPSULE / ORAL2014-02-24a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RifabutinRIFABUTINMylan Pharmaceuticals Inc.c2026b67-4755-4236-96b6-a6b5e73997072026-07-20Warnings, Adverse reactionsName fallback
brand name: Rifabutin
generic name: RIFABUTIN
RifabutinRIFABUTINREMEDYREPACK INC.754d2d7f-f0db-4f89-8fcd-5e2ff52d50302026-06-05Warnings, Adverse reactionsName fallback
brand name: Rifabutin
generic name: RIFABUTIN
RifabutinRIFABUTINA2A Integrated Pharmaceuticals10fb5949-5572-47bd-aaf0-018d9978cad82026-05-15Warnings, Adverse reactionsName fallback
brand name: Rifabutin
generic name: RIFABUTIN
RifabutinRIFABUTINi3 Pharmaceuticals, LLCfd6062e2-17c8-48f4-a1fe-69ebe410f5832026-02-20Warnings, Adverse reactionsName fallback
brand name: Rifabutin
generic name: RIFABUTIN
RifabutinRIFABUTINMarlex Pharmaceuticals, Inc.df7d4103-42e4-4e4f-e053-2a95a90a8ce82025-11-18Warnings, Adverse reactionsName fallback
brand name: Rifabutin
generic name: RIFABUTIN
RifabutinRIFABUTINREMEDYREPACK INC.25a60937-cbbe-4a50-994f-2ce15203f5892025-09-30Warnings, Adverse reactionsName fallback
brand name: Rifabutin
generic name: RIFABUTIN
RifabutinRIFABUTINANI Pharmaceuticals, Inc.baf8ec98-bd0c-4b87-a7ee-813335431b892025-02-13Warnings, Adverse reactionsName fallback
brand name: Rifabutin
generic name: RIFABUTIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60687-198rifabutinrifabutinAmerican Health PackagingANDACurrent
60687-198RifabutinRifabutinAmerican Health PackagingANDACurrent
60687-198RifabutinRifabutinAmerican Health PackagingANDACurrent
68180-285rifabutinrifabutinLupin Pharmaceuticals, Inc.ANDACurrent
68180-285rifabutinrifabutinLupin Pharmaceuticals, Inc.ANDACurrent
68180-285rifabutinrifabutinLupin Pharmaceuticals, Inc.ANDACurrent
68180-285rifabutinrifabutinLupin Pharmaceuticals, Inc.ANDACurrent
68180-285rifabutinrifabutinLupin Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9251ORIG2014-02-26