Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
PSS World Medical, Inc.
101822682
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Dispensing Solutions, Inc.
Dispensing Solutions, Inc.
PSS World Medical, Inc.
066070785
Products1
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
66336-429Application Number
ANDA065145Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 2, 2012GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4Class: IACT
ClarithromycinActive
Code: H1250JIK0AClass: ACTIBQuantity: 500 mg in 1 1
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
SODIUM PHOSPHATE, MONOBASIC ANHYDROUSInactive
Code: KH7I04HPUUClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
POLYETHYLENE GLYCOL 3000Inactive
Code: SA1B764746Class: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT