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
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