203697Orig1s000 - Food and Drug Administration
CENTER FOR DRUG EVALUATION AND
RESEARCH
APPLICATION NUMBER:
203697Orig1s000
CLINICAL PHARMACOLOGY AND
BIOPHARMACEUTICS REVIEW(S)
RECOMMENDATION
The Biopharmaceutics team has reviewed the information included in NDA 203-697.
From the Biopharmaceutics perspective NDA 203-697 for PL2200, aspirin
(acetylsalicylic acid) capsule is recommended for approval.
________________________________
Tien-Mien Chen, Ph.D.
ONDQA Biopharmaceutics Reviewer
______12/02/12_______
Date
________________________________
Angelica Dorantes, Ph.D.
ONDQA Biopharmaceutics Team Leader
______12/09/12_______
Date
CC:
DARRTS/NDA 203697/RLostritto
3
Reference ID: 3228086
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