Product: Drugs Recipient: Recipient Name Eric C. Ritter Spirochaete Research Labs, LLC aka Scitus Laboratory Products 822 Terry Rd.Hauppauge, NY 11788United States [email protected] Issuing Office: Center […]

Submit Comments by 05/13/2024 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

[3-11-2024] Today, FDA issued a revised draft guidance, Early Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industry. Once finalized, the guidance will provide recommendations to help […]

Submit Comments by 06/10/2024 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]

The REMS Public Dashboard is an interactive web-based tool that will allow for the analysis of REMS data in a user-friendly way. The intention of this […]

Login, complete evaluation, and print certificate Navigate to https://ceportal.fda.gov/ If you have an account, please login If you do not have an account, click on “Create […]

Login, complete evaluation, and print certificate Navigate to https://ceportal.fda.gov/ If you have an account, please login If you do not have an account, click on “Create […]

90 208237 Memantine and Donepezil Hydrochloride Extended-Release Capsules, 21 mg/10 mg and 28 mg/10 mg ANI Pharmaceuticals, Inc. Namzaric (Memantine and Donepezil Hydrochloride) Extended-Release Capsules 12/15/2023 […]