federal_register: 2019-28270

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2019-28270 Determination That GLUCOPHAGE (Metformin Hydrochloride) Oral Tablets, 500 Milligrams, 850 Milligrams, and 1 Gram, and GLUCOPHAGE XR (Metformin Hydrochloride) Oral Extended-Release Tablets, 500 Milligrams and 750 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice The Food and Drug Administration (FDA, Agency, or we) has determined that, GLUCOPHAGE (metformin hydrochloride) oral tablets, 500 milligrams (mg), 850 mg, and 1 gram (g), and GLUCOPHAGE XR (metformin hydrochloride) oral extended-release tablets, 500 mg and 750 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requirements. 2019-12-31 2019 12 https://www.federalregister.gov/documents/2019/12/31/2019-28270/determination-that-glucophage-metformin-hydrochloride-oral-tablets-500-milligrams-850-milligrams-and https://www.govinfo.gov/content/pkg/FR-2019-12-31/pdf/2019-28270.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, Agency, or we) has determined that, GLUCOPHAGE (metformin hydrochloride) oral tablets, 500 milligrams (mg), 850 mg, and 1 gram (g), and GLUCOPHAGE XR (metformin hydrochloride) oral extended-release tablets, 500 mg...  

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