FDA.reportPublic FDA data

Application 061809

Type
ANDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLEOCINCLINDAMYCIN HYDROCHLORIDECAPSULE;ORALEQ 75MG BASENoNo
002CLEOCINCLINDAMYCIN HYDROCHLORIDECAPSULE;ORALEQ 150MG 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
A061809-001CLEOCINCLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALApproved before 1982
A061809-002CLEOCINCLINDAMYCIN HYDROCHLORIDEEQ 150MG 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 UTC2022-10A061809-001CLEOCINEQ 75MG BASECAPSULE / ORALApproved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A061809-002CLEOCINEQ 150MG BASECAPSULE / ORALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A061809-001CLEOCINEQ 75MG BASECAPSULE / ORALApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09A061809-002CLEOCINEQ 150MG BASECAPSULE / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A061809-001CLEOCINEQ 75MG BASECAPSULE / ORALApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A061809-002CLEOCINEQ 150MG BASECAPSULE / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A061809-001CLEOCINEQ 75MG BASECAPSULE / ORALApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A061809-002CLEOCINEQ 150MG 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 4 · 74 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEREMEDYREPACK INC.fa084aad-07fa-44d2-8d01-d32f40acd2f32026-09-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDECardinal Health 107, LLCb22be885-f441-473e-879a-862588dcf89d2026-08-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEREMEDYREPACK INC.7f7fc73a-86e1-4d3e-8c83-1c74621e4af42026-07-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEHAWAII REPACK, INC.c6703df0-b41d-439f-8e0d-d30b3039b3f82026-07-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDESt. Mary's Medical Park Pharmacy1dd9e6b0-bcf4-5bf4-e063-6394a90a10c22026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEMajor Pharmaceuticalsd53a66bf-fdbd-4a12-8d8c-4e3ab94e9ef52026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.8e3c9cf6-ab39-4fb5-94e3-232880c477002026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.de7001d1-8b83-4f8b-8e50-c076910214562026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.fadc321a-2291-4268-936f-0743fdddbe7f2026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEMajor Pharmaceuticalsf9e6ed50-ad03-4a9e-8760-8733e04a058c2026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.1dbd8448-c1e5-46df-8060-50ef823804452026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepack47f76d99-2024-4531-a527-66c80deeeb372026-06-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepack5f6a85c5-dca3-49b1-a029-3818a41d49bf2026-06-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY1f1b9230-b8ef-b0e4-e063-6394a90afc472026-06-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEUnit Dose Solutions, Inc.535e7e17-d020-4aa6-e063-6294a90ae1142026-06-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDESt. Mary's Medical Park Pharmacyafeb96ed-7c2e-72d3-e053-2995a90a4ed32026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEGolden State Medical Supply, Inc.a69260bb-31b5-4f77-e053-2995a90a37e12026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepacke4d91d51-b92e-4d3e-8379-f9463f4505372026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEProficient Rx LPd1aa1e91-4ac8-40d1-9fc4-963e1c9c32782026-05-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDECoupler LLC509a9bc3-0901-0874-e063-6294a90a88162026-04-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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