Strides Pharma submitted an original Abbreviated New Drug Application (ANDA) identified as ANDA202002 for a topical cream containing 5% IMIQUIMOD. The product is listed under product number 001 and is currently marked as discontinued.
The submission package includes a letter dated June 26, 2014 (document ID 9939) accessible via the FDA website. The submission status is recorded as AP (approved) with a status date of June 24, 2014.
For full details, refer to the FDA’s official submission letter: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202002Orig1s000ltr.pdf
規制動向2026年9月16日•3分で読めます
FDA ANDA202002: Strides Pharma Submits Original Application for IMIQUIMOD 5% Cream
Strides Pharma filed ANDA202002 for a 5% IMIQUIMOD topical cream (product 001). The original submission was listed as approved on 24‑Jun‑2014.
Pharmacountryチームがまとめました · 出典： FDA
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