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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
AvPAK
DUNS: 832926666
Effective Date
January 9, 2024
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
50268-179
Application Number
ANDA065489
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 9, 2024
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0WClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
VANILLINInactive
Code: CHI530446XClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SORBIC ACIDInactive
Code: X045WJ989BClass: IACT
Code: H1250JIK0AClass: ACTIBQuantity: 500 mg in 1 1

Clarithromycin

Product Details

NDC Product Code
50268-178
Application Number
ANDA065489
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 9, 2024
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
VANILLINInactive
Code: CHI530446XClass: IACT
Code: H1250JIK0AClass: ACTIBQuantity: 250 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0WClass: IACT
SORBIC ACIDInactive
Code: X045WJ989BClass: IACT
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