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 4 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions2393251d-33b9-4274-9d04-27ec9968eaa12024-05-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEChartwell RX, LLCe8167412-882e-4143-93c6-49e68adbcf162024-01-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEAvPAKb2a810f1-c009-e973-e053-2a95a90ad5b02024-01-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLINDAMYCIN HYDROCHLORIDE
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions337870c6-11e0-4d1a-a26e-afe042ee08c32024-01-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEAmneal Pharmaceuticals NY LLCe08eea9e-464c-429e-9584-b768f51277672023-12-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: clindamycin hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions600c5ac7-64f7-44ac-9e83-cc1036471eec2023-12-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions22bf9385-cad3-43a7-802f-131b6826b5a52023-09-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEAsclemed USA, Inc.cd5a1db8-9ddf-4de3-b856-bc3e8fb290612023-05-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions07f5d841-9c58-4dd1-b0bc-e12553931c8e2023-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLINDAMYCIN HYDROCHLORIDE
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions18ef4551-4066-4765-90cb-285d7711cf612023-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLINDAMYCIN HYDROCHLORIDE
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEProficient Rx LPf7e51a42-bc9e-490f-b8d8-8765f0b5be462022-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLINDAMYCIN HYDROCHLORIDE
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEProficient Rx LP158e6c0c-1ca3-49a6-84fd-54d8fde7c2a72022-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEProficient Rx LPd6e1a5f2-9dcb-49fb-a5b0-d7d543520ac32022-04-01Boxed 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