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 3 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepackcd2ca915-5672-440d-a14e-b4d3b6a522f32025-09-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLINDAMYCIN HYDROCHLORIDE
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEDIRECT RXc3f35f80-e4ae-95f5-e053-2995a90a1b642025-07-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLINDAMYCIN HYDROCHLORIDE
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEAmerican Health Packaging3f6b2c5a-e581-414f-bc9e-eaf66a5685cd2025-06-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.12dea490-e179-f295-e063-6394a90af4aa2025-04-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEBrisk Pharmaceuticals2de041be-1d36-ee95-e063-6294a90a20912025-02-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.2178249b-a9fe-5015-e063-6294a90a9ff42024-12-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEQuality Care Products, LLC1d562ae9-5a9a-4fed-8cc7-3f30fb40f9572024-12-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLINDAMYCIN HYDROCHLORIDE
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions7b110bab-815e-4654-860b-b9142fd93d452024-10-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.2290109b-45c9-1aab-e063-6294a90a673b2024-09-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepack2b13d66d-4f48-477e-ba32-20e85d0e708d2024-09-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepack7537fbab-c792-4b77-8736-c24b69cf48ea2024-09-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEA-S Medication Solutions8af1493c-1f22-4629-a432-f8b0578189e12024-09-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.11e8dd9c-81fd-4e88-e063-6294a90af13e2024-09-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin Hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepackbea7de4c-c077-4535-96a0-f6b319120b0b2024-08-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLINDAMYCIN HYDROCHLORIDE
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.b2bd8402-c887-5bfd-e053-2a95a90a15d92024-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEAdvanced Rx of Tennessee, LLC1d760cb7-d166-6707-e063-6394a90a88502024-07-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLINDAMYCIN HYDROCHLORIDE
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.9e68cb17-73d9-8a00-e053-2995a90a517f2024-06-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLINDAMYCIN HYDROCHLORIDE
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.9fe44bdd-eb59-4b55-e053-2995a90a31832024-06-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLINDAMYCIN HYDROCHLORIDE
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.678912ff-a0c1-171b-e053-2991aa0ad1282024-06-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clindamycin hydrochloride
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.63f26644-b7ab-98c1-e053-2a91aa0af5d32024-06-06Boxed 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