Masti-Kure Products Co., Inc. v. Califano, MASTI-KURE
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- Code of Federal Regulations - Applicability of ''new drug'' or safety or effectiveness findings in drug efficacy study implementation notices and notices of opportunity for hearing to identical, related, and similar drug products
- Code of Federal Regulations - Applications
- Code of Federal Regulations - Refusal to approve an application
- Code of Federal Regulations - Withdrawal of approval of applications
- US Code - 21 U.S.C. § 321 Definitions; Generally