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FDA Approval

CLARITHROMYCIN

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Chartwell RX, LLC.
DUNS: 079394054
Effective Date
December 23, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Clarithromycin(500 mg in 1 1)

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

CLARITHROMYCIN

Product Details

NDC Product Code
62135-615
Application Number
ANDA065384
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 23, 2022
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Code: H1250JIK0AClass: ACTIBQuantity: 500 mg in 1 1

CLARITHROMYCIN

Product Details

NDC Product Code
62135-616
Application Number
ANDA065384
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 23, 2022
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Code: H1250JIK0AClass: ACTIBQuantity: 250 mg in 1 1
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