Determine whether Chloramphenicol Capsules 250 mg was withdrawn from sale for reasons other than safety or effectiveness and grant permission to relist application number A060851

 
Docket ID: FDA-2011-P-0081
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Summary:
Status: OPEN Request for Reconsideration received 12/18/15
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Keyword(s): Chloramphenicol Capsules, USP 250 mg, ANDA, CDER, Petition for Reconsideration, 21 CFR 314.153(b)(2), Armenpharm, Ltd. (Armenpharm), requesting that the FDA consider not just, whether the original NDA for, Chloramphenicol Capsules USP, 250 mg, (ANDA 060851), was withdrawn for reasons of safety, but whether, an approved generic sponsor, like Armenpharm, might be permitted to make this important, antibiotic and develop and implement elements, REMS program… a request to an oral hearing, if FDA elects to suspend approval of this ANDA, OPEN, Appeal AIMS # 2015-7904, CDER-OGD
Legacy ID: 2015-7904
Type: Nonrulemaking
Docket Status: OPEN
Center: CDER-OGD
Docket Item Code: P
 

Primary Documents

View All  (9)
Comment Period Closed
Notice
Posted: 09/21/2016
ID: FDA-2011-P-0081-0021
Other
Posted: 12/24/2015
ID: FDA-2011-P-0081-0014
Comment Period Closed
Other
Posted: 12/24/2015
ID: FDA-2011-P-0081-0015
Other
Posted: 12/03/2015
ID: FDA-2011-P-0081-0012
Comment Period Closed
Other
Posted: 07/31/2012
ID: FDA-2011-P-0081-0011

Supporting Documents

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Comments Not Accepted
Supporting & Related Material
Posted: 12/28/2015
ID: FDA-2011-P-0081-0020
Comments Not Accepted
Supporting & Related Material
Posted: 12/28/2015
ID: FDA-2011-P-0081-0019
Comments Not Accepted
Supporting & Related Material
Posted: 12/28/2015
ID: FDA-2011-P-0081-0018

Comments

View All  (1)

2
Comments Received*
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