CHLORPROMAZINE HYDROCHLORIDE | A080439 | CHARTWELL RX SCIENCES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from PTS Consulting FDA-2016-P-1250 · 6 docket documents PTS Consulting filed this citizen petition under Section 505(j) of the FDC Act requesting that the FDA designate Chlorpromazine Hydrochloride Tablets, 100 mg, ANDA No. 084114, held by USL Pharma, as a second reference-listed drug in the Orange Book because the original RLD, Sandoz's ANDA No. 080439, | Other | 2016-05-10 | Withdrawn | PTS Consulting |
Citizen Petition Request from Lachman Consultant Services Inc FDA-2014-P-1844 · 5 docket documents Lachman Consultant Services Inc., on behalf of a client, filed this petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA amend the Orange Book to designate Chlorpromazine Hydrochloride Tablets, 100 mg, ANDA No. 084114, held by USL Pharma as a second refer | 505(q) | 2014-11-05 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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