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Get Manual Of Policies And Procedures On Scoring Configuration Of Generic Drug Products 5223 2

Ts. Generally, if the listed drug deletes a score solely on its own initiative, the generic product's scoring configuration may be either scored or unscored. However, if the listed drug adds a score, the generic product generally should follow the same configuration. These cases will be handled on an individual basis as they occur. OGD recognizes that a reasonable time is necessary to accomplish the manufacturing revisions needed to implement a scoring change. Generally, "reasonable time" is con.

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