FDA TIMOPTIC NDA 018086 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for TIMOPTIC, NDA 018086. The package contains 16 FDA documents totaling 190 pages, organized by original application and supplemental submission.

Research-ready collection with the FDA documents preserved as individual PDFs and organized by regulatory submission.

What's included

• Original FDA approval records
• 9 supplemental submissions represented
• 2 FDA review documents
• 7 approval letters
• 7 labeling documents
• FOIAdocs document index and detailed manifest

Package format: Organized ZIP collection with individual FDA PDFs grouped by regulatory submission, plus a FOIAdocs document index and manifest.

Application: NDA 018086
Product: TIMOPTIC
Sponsor: BAUSCH AND LOMB INC
Documents: 16
Pages: 190
Coverage: Original approval + 9 supplemental submissions represented