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It must comply with an applicable U.S

Paradoxical reactions may be experienced

Triscari, J

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The 180-Day First-Filer Exclusivity: The Most Valuable Short-Term IP Asset in Generics The first ANDA applicant to file a Paragraph IV certification against a given patent earns a 180-day period during which the FDA will not approve any other ANDA for the same drug

To overcome this barrier, enzyme inhibitors have been incorporated into buccal delivery systems to protect peptides from enzymatic cleavage, thereby enhancing their stability and mucosal absorption