MedWatch - August 2001 Safety-Related Drug Labeling Changes
...concentration as a function of total container content rather than content per mL. This change was.....Contact the company for a copy of the new carton/container labeling. OVERDOSAGE: There is.....Due to its benzyl alcohol content, Dopram Injectable is contraindicated ..should not be..
http://www.fda.gov/medwatch/safety/2001/aug01.htm (score=100)

MDI and DPI Drug Products
...Documentation in Drug Applications for Container and Closure Systems Used for the.....distribution, crystallinity, dose content uniformity, microbial content, and stability.....elastomeric, plastic components or coatings of the container and closure system when in..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=36)

/a//content.961

http://www.fda.gov/cder/dmpq/frn7297.pdf (score=32)

Guidance- Content & Format CMC for Vaccine & Related Product
...A description of the container and closure system, and its compatibility with the drug.....This guidance document represents FDA's current thinking on the content and format of the.....intended to be sterile, evidence of container and closure integrity for the duration of..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=31)

/a//content.21607

http://www.fda.gov/cder/dmpq/frpr7297.pdf (score=31)

Selected Guidance Documents Applicable to Combination Products
...Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the.....Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial.....Content and Format of the Adverse Reactions Section of Labeling for Human Prescription..
http://www.fda.gov/oc/combination/guidance.html (score=30)

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