SULFAMETHOXAZOLE; TRIMETHOPRIM | A074650 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Lachman Consultant Services, Inc. FDA-2019-P-0198 · 6 docket documents Lachman Consultant Services, Inc., acting as the US Agent for NaviSci Pte Ltd, filed this petition requesting that the FDA designate an additional reference standard for Sulfamethoxazole and Trimethoprim Oral Suspension in the Orange Book to support an ANDA submission, citing that the current refere | Other | 2019-01-14 | Denied | Lachman Consultant Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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