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This determination allows FDA to approve any future or pending abbreviated new drug applications for this product, if all other legal and regulatory requirements are met.
United StatesFood, Drugs, Healthcare, Life Sciences
In the May 13, 2015, Federal Register, FDA announced it determined
that SODIUM SULAMYD (sulfacetamide sodium) Ophthalmic Solution and
Ophthalmic Ointment were not withdrawn due to safety or
effectiveness reasons. This determination allows FDA to approve any
future or pending abbreviated new drug applications for this
product, if all other legal and regulatory requirements are
met.
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