Bausch

FDA Filings

This page includes the latest FDA filings for Bausch. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
204884 ANDA BAUSCH		2021-08-24 20:09:16
208158 ANDA BAUSCH		2020-09-30 18:52:44
211882 NDA BAUSCH		0000-00-00 00:00:00
211039 NDA BAUSCH		0000-00-00 00:00:00
210821 NDA BAUSCH		0000-00-00 00:00:00
209355 NDA BAUSCH		0000-00-00 00:00:00
209354 NDA BAUSCH		0000-00-00 00:00:00
203567 NDA BAUSCH		0000-00-00 00:00:00
080442 ANDA BAUSCH		0000-00-00 00:00:00
080426 ANDA BAUSCH		0000-00-00 00:00:00
050819 NDA BAUSCH		0000-00-00 00:00:00
050782 NDA BAUSCH		0000-00-00 00:00:00
050756 NDA BAUSCH		0000-00-00 00:00:00
050649 NDA BAUSCH		0000-00-00 00:00:00
050584 NDA BAUSCH		0000-00-00 00:00:00
050445 NDA BAUSCH		0000-00-00 00:00:00
022483 NDA BAUSCH		0000-00-00 00:00:00
022436 NDA BAUSCH		0000-00-00 00:00:00
022076 NDA BAUSCH		0000-00-00 00:00:00
021479 NDA BAUSCH		0000-00-00 00:00:00
021478 NDA BAUSCH		0000-00-00 00:00:00
021392 NDA BAUSCH		0000-00-00 00:00:00
021385 NDA BAUSCH		0000-00-00 00:00:00
021302 NDA BAUSCH		0000-00-00 00:00:00
021271 BLA BAUSCH		0000-00-00 00:00:00
021159 NDA BAUSCH		0000-00-00 00:00:00
021056 NDA BAUSCH		0000-00-00 00:00:00

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• Bausch + Lomb Ireland Limited400 Somerset Corporate Blvdbridgewater, NJ 08807 PMA NumberP050026 Supplement NumberS002 Date Received09/04/2020 Decision Date01/20/2023 Product Code MVF  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Bausch & Lomb, Inc.1400 North Goodman St.rochester, NY 14609-3547 PMA NumberP980006 Supplement NumberS035 Date Received08/12/2022 Decision Date09/29/2022 Product Code LPM  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Bausch & Lomb, Inc.50 Technology Driveirvine, CA 92618 PMA NumberP060022 Supplement NumberS030 Date Received08/16/2022 Decision Date09/20/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Bausch & Lomb, Inc.50 Technologyirvine, CA 92618 PMA NumberP840039 Supplement NumberS064 Date Received07/11/2022 Decision Date08/09/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Bausch And Lomb, Inc.1400 North Goodman Streetrochester, NY 14609 PMA NumberP170035 Supplement NumberS017 Date Received05/04/2022 Decision Date06/01/2022 Product Code LPM  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Bausch & Lomb, Inc.1400 North Goodman St.rochester, NY 14609-3547 PMA NumberP980006 Supplement NumberS034 Date Received02/22/2022 Decision Date03/21/2022 Product Code LPM  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Bausch And Lomb, Inc.1400 North Goodman Streetrochester, NY 14609 PMA NumberP170035 Supplement NumberS016 Date Received02/22/2022 Decision Date03/21/2022 Product Code LPM  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Bausch & Lomb, Inc.14853 Deveau Placeminnetonka, MN 55345 PMA NumberP850068 Supplement NumberS014 Date Received02/01/2022 Decision Date03/18/2022 Product Code LPM  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
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