FDA.reportPublic FDA data

Application 050316

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LINCOCINLINCOMYCIN HYDROCHLORIDECAPSULE;ORALEQ 250MG BASENoNo
002LINCOCINLINCOMYCIN HYDROCHLORIDECAPSULE;ORALEQ 500MG BASENoNo

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
N050316-001LINCOCINLINCOMYCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALApproved before 1982
N050316-002LINCOCINLINCOMYCIN HYDROCHLORIDEEQ 500MG BASECAPSULE / ORALApproved 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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N050316-001LINCOCINEQ 250MG BASECAPSULE / ORALApproved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N050316-002LINCOCINEQ 500MG BASECAPSULE / ORALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050316-001LINCOCINEQ 250MG BASECAPSULE / ORALApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N050316-002LINCOCINEQ 500MG BASECAPSULE / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050316-001LINCOCINEQ 250MG BASECAPSULE / ORALApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050316-002LINCOCINEQ 500MG BASECAPSULE / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050316-001LINCOCINEQ 250MG BASECAPSULE / ORALApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050316-002LINCOCINEQ 500MG BASECAPSULE / ORALApproved before 1982a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LINCOMYCINLINCOMYCIN HYDROCHLORIDEHenry Schein, Inc.a7692968-7ac8-48ab-89a4-27c7803e31f42025-10-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LINCOMYCIN HYDROCHLORIDE
LincocinLINCOMYCIN HYDROCHLORIDEPharmacia & Upjohn Company LLCc01906fa-2c73-4c13-9765-2fd06628d2632025-03-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lincocin
generic name: LINCOMYCIN HYDROCHLORIDE
LincomycinLINCOMYCIN HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma23f9608c-3126-35db-e063-6294a90af0542024-10-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LINCOMYCIN HYDROCHLORIDE
LincomycinLINCOMYCIN HYDROCHLORIDESagent Pharmaceuticals75e149cc-b668-427e-bae7-a0d215e4fb7a2023-03-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LINCOMYCIN HYDROCHLORIDE
LincomycinLINCOMYCIN HYDROCHLORIDEXGen Pharmaceuticals DJB, Inc.61f4851d-d919-400d-912a-05eb9dca11d42022-10-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LINCOMYCIN HYDROCHLORIDE
lincomycin hydrochlorideLINCOMYCIN HYDROCHLORIDEGland Pharma Limitedc2b5be20-cc6f-4221-9d3e-3f8b5886cd052022-09-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LINCOMYCIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
7726SUPPL2004-06-07