Docket Number: FDA-2020-D-1530 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA, Agency, or we) is announcing the […]

Recommended Acceptable Intake (AI) Limits and Testing Methods On 8/4/2023, FDA issued a final guidance on Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) […]

[04/06/2021] Update: FDA recommended several times that Amazon.com recall this product to protect consumers, most recently on January 29, 2021. However, Amazon.com has not done so. See FDA’s press release for additional information. [12-17-2020] The Food and Drug […]

[05-06-2021] Update: This product has been recalled by NS NY Distributor Inc. See the company’s press release for more information on the recall. This product was sold by NS […]

[06-15-2021] Update: This product has been recalled by miracle8989. See the company’s press release for more information on the recall. This product was sold by miracle8989 via eBay. [12-17-2020] The Food […]

Potential applicants are encouraged to contact the FDA Generic Drugs Program with questions at any point in their development and ANDA preparation processes. For inquiries related […]

Docket Number: FDA-2018-D-1434 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research The Food and Drug Administration (FDA […]

[06-15-2021] Update: This product has been recalled by miracle8989. See the company’s press release for more information on the recall. This product was sold by miracle8989 via eBay. [12-17-2020] The Food […]

[04/16/2021] Update: This product has been recalled by QMART. See the company’s press release for more information on the recall. This product was sold by QMART via Amazon fulfillment. See FDA’s press release for […]