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Entreprise · 19/07/19991 min de lecture
SoloPak Laboratories, Inc.; Withdrawal of Approval of 1 New Drug Application and 38 Abbreviated New Drug Applications; Correction
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Résumé
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 21, 1999 (64 FR 33097). The document announced the withdrawal of approval of 1 new drug application (NDA) and 38 abbreviated new drug applications (ANDA's) held by SoloPak Laboratories, Inc. The document omitted language explaining that the sponsor voluntarily removed the products from the market because of discrepancies concerning the data submitted to support continued approval of the applications. This document corrects that omission.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →