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Research Criteria and Technical Notes

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Latest updates

Product: Casporyn®(hydrocortisone, neomycin and polymyxin B sulfate) Otic Suspension/Drops
Company: Casper Pharma
Petition Filer: Lachman Consulting
Petition Number(s): 2020P-2004
Date of Petition: October 6, 2020
Responding Petitions:

Issue and Implication: Whether FDA can designate a second Reference Standard when the current RS…[Read more]

Profile picture of gregoryglass 2 weeks ago

Product: Acetazolamide Injection
Company: Mylan
Petition Filer: University of Kentucky
Petition Number(s): 2020P-2033
Date of Petition: October 1, 2020
Responding Petitions:

Issue and Implication: Whether FDA should remove from market certain products based on quality testing irregularities.

Action Requested by Petitioner: The…[Read more]

Profile picture of gregoryglass 2 weeks, 5 days ago

Product: K-Tab®(potassium chloride) Extended-release Tablets
Company: Merck
Petition Filer: 2018P-0870
Petition Number(s): 2018P-0870
Date of First Petition: February 26, 2018
Responding Petitions: None

Action Requested of Petition: The Petitioner would like to file an ANDA for the 15 mEq (1125mg) extended-release tablets for…[Read more]

Profile picture of gregoryglass 3 weeks, 6 days ago
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