SODIUM FERRIC GLUCONATE COMPLEX | A078215 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Watson Pharma, Inc. FDA-2004-P-0494 Watson Pharma, Inc. filed this citizen petition in February 2004 requesting that the FDA withhold approval of any Abbreviated New Drug Application for generic sodium ferric gluconate complex in sucrose (Ferrlecit®) unless the generic product is manufactured using the identical process as Watson's pr | 505(q) | 2009-08-10 | Partially Denied | Watson Pharma |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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