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 2 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEREMEDYREPACK INC.87db8bce-1b6f-4f1b-ab62-b3778c429b2e2026-04-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.4f0ddf1a-eda6-8ca8-e063-6294a90a41022026-04-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEAurobindo Pharma Limited2367340c-d297-4a3f-8253-6d27a0ed39cb2026-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.51dfa3fa-6f6a-4904-a8d3-b5938cf9c8522026-03-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.adf8f0fa-f794-4e97-a7b3-16b55d9c9a682026-03-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEGLENMARK PHARMACEUTICALS INC., USA8e66de7a-d9d4-4562-bc99-80489d482da42026-03-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.bde81d4b-ad21-cc09-e053-2995a90a8c012026-02-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLINDAMYCIN HYDROCHLORIDE
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.ba9bd5cd-036b-4b0c-e053-2a95a90a332e2026-02-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLINDAMYCIN HYDROCHLORIDE
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDESportpharm LLC3bddb5d2-ddac-2f03-e063-6294a90aa68c2026-02-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEA-S Medication Solutionsebdcd3ce-3140-4bf6-b8b8-468ead08d9a92026-02-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDERedPharm Drug, Inc.a2f6fa76-a114-4104-e053-2a95a90a9e0b2026-01-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLINDAMYCIN HYDROCHLORIDE
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDENorthwind Health Company, LLCf2f08e98-f6c5-7c2d-e053-2995a90abe1e2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDENorthwind Health Company, LLCf781897a-ab54-7373-e053-6294a90a89a32026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDENorthwind Health Company, LLCf6f5c8b2-83a1-5362-e053-6394a90aaaad2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLINDAMYCIN HYDROCHLORIDE
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.4730ab20-09e2-d32a-e063-6394a90ae1252025-12-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDERedpharm Drug0a0fbeae-2bc2-2402-e063-6394a90a97a02025-12-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDERedpharm Drug3256c93b-f26c-aeb9-e063-6394a90ae9c22025-12-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEVERITYRX, LLC427a0138-c2dd-cf0b-e063-6394a90af4072025-10-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions09eea0ad-702f-4eea-bfb9-81effc76b22b2025-10-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions9fe68a5a-487b-4119-9ee7-603948d732e42025-09-23Boxed 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