FDA.reportPublic FDA data

Application 065242

Type
ANDA
Sponsor
LANNETT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDECAPSULE;ORALEQ 75MG BASENoNo
002CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDECAPSULE;ORALEQ 150MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog.

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 · 73 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
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDECardinal Health 107, LLCb22be885-f441-473e-879a-862588dcf89d2026-08-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEREMEDYREPACK INC.7f7fc73a-86e1-4d3e-8c83-1c74621e4af42026-07-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEHAWAII REPACK, INC.c6703df0-b41d-439f-8e0d-d30b3039b3f82026-07-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDESt. Mary's Medical Park Pharmacy1dd9e6b0-bcf4-5bf4-e063-6394a90a10c22026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEMajor Pharmaceuticalsd53a66bf-fdbd-4a12-8d8c-4e3ab94e9ef52026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.8e3c9cf6-ab39-4fb5-94e3-232880c477002026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLINDAMYCIN HYDROCHLORIDE
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.de7001d1-8b83-4f8b-8e50-c076910214562026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLINDAMYCIN HYDROCHLORIDE
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.fadc321a-2291-4268-936f-0743fdddbe7f2026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEMajor Pharmaceuticalsf9e6ed50-ad03-4a9e-8760-8733e04a058c2026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.1dbd8448-c1e5-46df-8060-50ef823804452026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepack47f76d99-2024-4531-a527-66c80deeeb372026-06-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepack5f6a85c5-dca3-49b1-a029-3818a41d49bf2026-06-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLINDAMYCIN HYDROCHLORIDE
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY1f1b9230-b8ef-b0e4-e063-6394a90afc472026-06-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEUnit Dose Solutions, Inc.535e7e17-d020-4aa6-e063-6294a90ae1142026-06-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDESt. Mary's Medical Park Pharmacyafeb96ed-7c2e-72d3-e053-2995a90a4ed32026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLINDAMYCIN HYDROCHLORIDE
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEGolden State Medical Supply, Inc.a69260bb-31b5-4f77-e053-2995a90a37e12026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepacke4d91d51-b92e-4d3e-8379-f9463f4505372026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEProficient Rx LPd1aa1e91-4ac8-40d1-9fc4-963e1c9c32782026-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDECoupler LLC509a9bc3-0901-0874-e063-6294a90a88162026-04-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE

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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-1381Clindamycin HydrochlorideClindamycin HydrochlorideLannett Company, Inc.ANDACurrent
0527-1382Clindamycin HydrochlorideClindamycin HydrochlorideLannett Company, Inc.ANDACurrent
43063-394Clindamycin HydrochlorideClindamycin HydrochloridePD-Rx Pharmaceuticals, InANDACurrent
43063-394Clindamycin HydrochlorideClindamycin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-394Clindamycin HydrochlorideClindamycin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-394Clindamycin HydrochlorideClindamycin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-394Clindamycin HydrochlorideClindamycin HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-3703Clindamycin HydrochlorideClindamycin HydrochlorideA-S Medication SolutionsANDACurrent
50090-3703Clindamycin HydrochlorideClindamycin HydrochlorideA-S Medication SolutionsANDACurrent
60760-337Clindamycin HydrochlorideClindamycin HydrochlorideSt. MaryANDACurrent
60760-337Clindamycin HydrochlorideClindamycin HydrochlorideSt. MaryANDACurrent
70934-144Clindamycin HydrochlorideClindamycin HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-144Clindamycin HydrochlorideClindamycin HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-144Clindamycin HydrochlorideClindamycin HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent