FDA.reportPublic FDA data

Application 061827

Type
ANDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLEOCINCLINDAMYCIN PALMITATE HYDROCHLORIDEFOR SOLUTION;ORALEQ 75MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo

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

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
A061827-001CLEOCINCLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALApproved before 1982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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A061827-001CLEOCINEQ 75MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A061827-001CLEOCINEQ 75MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A061827-001CLEOCINEQ 75MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A061827-001CLEOCINEQ 75MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALApproved before 1982a50c72e98297…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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin Palmitate Hydrochloride (Pediatric)CLINDAMYCIN PALMITATE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCfaf67eb8-1fd7-4b2c-a55b-24ba664c0dce2026-06-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN PALMITATE HYDROCHLORIDE
Cleocin PediatricCLINDAMYCIN PALMITATE HYDROCHLORIDEPharmacia & Upjohn Company LLC1ef87b6c-9d32-44ac-8c55-8bf01424cc452026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN PALMITATE HYDROCHLORIDE
CleocinCLINDAMYCIN PHOSPHATEPharmacia & Upjohn Company LLC3db26227-208d-4fdd-8426-1d9be5cda9b42026-03-09Warnings, Adverse reactionsName fallback
brand name: Cleocin
CleocinCLINDAMYCIN PHOSPHATEPharmacia & Upjohn Company LLCf9be442d-0782-4b93-828f-9ebbf67dbced2025-11-19Warnings, Adverse reactionsName fallback
brand name: Cleocin
Clindamycin Palmitate HydrochlorideCLINDAMYCIN PALMITATE HYDROCHLORIDEChartwell RX, LLC5d120b48-8181-4f40-a0e5-1f5cd0450d4f2025-09-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN PALMITATE HYDROCHLORIDE
CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric)CLINDAMYCIN PALMITATE HYDROCHLORIDERising Pharma Holdings, Inc.0800afad-e4cd-4f70-aaa1-a14547be47292025-04-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN PALMITATE HYDROCHLORIDE
CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric)CLINDAMYCIN PALMITATE HYDROCHLORIDEBryant Ranch Prepack3afe52c2-b65b-40fe-b2fa-da39f1bcf5292024-09-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN PALMITATE HYDROCHLORIDE
CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric)CLINDAMYCIN PALMITATE HYDROCHLORIDEBryant Ranch Prepack28ba03fd-0f9c-49c6-9bfb-cda5417801c62024-04-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN PALMITATE HYDROCHLORIDE
clindamycin palmitate hydrochlorideCLINDAMYCIN PALMITATE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.a2279019-9341-4346-8746-fea262b27dd82022-12-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN PALMITATE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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