GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36506
Submission : 2022-06-16
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28449
Submission : 2014-06-16
Status : Active
Type : IV
Certificate Number : R1-CEP 2016-283 - Rev 01
Status : Valid
Issue Date : 2023-01-12
Type : Chemical
Substance Number : 1444
Certificate Number : R1-CEP 2009-392 - Rev 01
Status : Valid
Issue Date : 2022-07-06
Type : Chemical
Substance Number : 1444
Macrogols, Types 3350 and 4000
Certificate Number : CEP 2006-085 - Rev 04
Status : Valid
Issue Date : 2024-09-18
Type : Chemical
Substance Number : 1444
FINISHED DOSAGE FORMULATIONS
Drug : CLARITHROMYCIN
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Application Number : 65154
Country : US
Patented : No