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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameCOMPLETE BRAND LUBRICATING AND REWETTING DROPS
Classification Nameaccessories, soft lens products
Regulation Number886.5928
ApplicantALLERGAN OPTICAL
PMA NumberP910075
Supplement NumberS004
Date Received04/06/1995
Decision Date12/05/1995
Product Code
LPN[ Registered Establishments with LPN ]
Docket Number n -
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following alternate manufacturing site:allergan america, puerto rico road 345 km 1. 5, hormigueros, puerto rico, 00660.
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