21 C.F.R. §201.10 - Drugs; statement of ingredients

Cite as21 C.F.R. §201.10
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8 cases
  • Medinatura, Inc. v. Food & Drug Admin., Civil Action No. 20-2066 (RDM)
    • United States
    • United States District Courts. United States District Court (Columbia)
    • October 23, 2020
    ...requirements, including:Statement of Ingredients: Ingredient information shall appear in accord with Section 502(e) of the Act and 21 CFR 201.10. Labeling must bear a statement of the quantity and amount of ingredient(s) in the product in conformance with Section 502(b) of the Act, as well ......
  • DeLarosa v. Boiron, Inc., Case No. 8:10–CV–1569–JST (CWx).
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Central District of California
    • July 25, 2011
    ...adequate directions for use, a statement of ingredients, the dilution, and at least one major OTC indication for use. See 21 C.F.R. §§ 201.5, 201.10, 201.61, 201.62. In determining whether the labeling or advertising is misleading, the Court should consider “not only representations made or......
  • Pharmacia Corp. v. Alcon Laboratories, Inc., Civ. No. 01-1539(WGB).
    • United States
    • United States District Courts. 3th Circuit. United States District Courts. 3th Circuit. District of New Jersey
    • May 14, 2002
    ...in spelling or pronunciation, may be confused with the proprietary name or the established name of a different drug or ingredient." 21 C.F.R. § 201.10(c)(5); see also 12/17 Tr., at 173 (Barton); Garanzini Tr., at 53. Prior to October 1999, the FDA name review process was conducted under the......
  • Al Haj v. Pfizer Inc.
    • United States
    • United States District Courts. 7th Circuit. United States District Court (Northern District of Illinois)
    • April 13, 2018
    ...them to use the term "Maximum Strength," see ibid. , and in fact forbids them from using "misleading" labels, see 21 U.S.C. § 352(a); 21 C.F.R. § 201.10(c). Because the complaint plausibly alleges that designating the product as "Maximum Strength" Robitussin was misleading, the ICFA's safe ......
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