이 기사의 번역을 준비하고 있습니다. 그동안 영어 원문을 임시로 표시합니다.
비즈니스 · 1999. 7. 19.1 분 읽기
SoloPak Laboratories, Inc.; Withdrawal of Approval of 1 New Drug Application and 38 Abbreviated New Drug Applications; Correction
로컬 자동 번역 · 원본 출처 언어
요약
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.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →