Collection: Available Now
Available for immediate download.
-
FDA DYMISTA NDA 202236 Approval Package — Reviews & Approval Records
Regular price $349.00 USDRegular priceUnit price / perSale price $349.00 USD -
FDA DYSPORT BLA 125274 Approval Package — Reviews & Approval Records
Regular price $479.00 USDRegular priceUnit price / perSale price $479.00 USD -
FDA EFFEXOR NDA 020151 Approval Package — Reviews & Approval Records
Regular price $459.00 USDRegular priceUnit price / perSale price $459.00 USD -
FDA EFFEXOR XR NDA 020699 Approval Package — Reviews & Approval Records
Regular price $609.00 USDRegular priceUnit price / perSale price $609.00 USD -
FDA EFUDEX NDA 016831 Approval Package — Reviews & Approval Records
Regular price $129.00 USDRegular priceUnit price / perSale price $129.00 USD -
FDA ELIDEL NDA 021302 Approval Package — Approval Records & Labeling
Regular price $169.00 USDRegular priceUnit price / perSale price $169.00 USD -
FDA ELMIRON NDA 020193 Approval Package — Reviews & Approval Records
Regular price $339.00 USDRegular priceUnit price / perSale price $339.00 USD -
FDA EMEND NDA 021549 Approval Package — Reviews & Approval Records
Regular price $459.00 USDRegular priceUnit price / perSale price $459.00 USD -
FDA EMEND NDA 022023 Approval Package — Reviews & Approval Records
Regular price $459.00 USDRegular priceUnit price / perSale price $459.00 USD -
FDA EMLA NDA 019941 Approval Package — Reviews & Approval Records
Regular price $239.00 USDRegular priceUnit price / perSale price $239.00 USD -
FDA EMSAM NDA 021336 Approval Package — Approval Records & Labeling
Regular price $169.00 USDRegular priceUnit price / perSale price $169.00 USD -
FDA EMSAM NDA 021708 Approval Package — Approval Records & Labeling
Regular price $169.00 USDRegular priceUnit price / perSale price $169.00 USD -
FDA EMTRIVA NDA 021500 Approval Package — Approval Records & Labeling
Regular price $229.00 USDRegular priceUnit price / perSale price $229.00 USD -
FDA ENBREL BLA 103795 Approval Package — Reviews & Approval Records
Regular price $579.00 USDRegular priceUnit price / perSale price $579.00 USD -
FDA ENTEREG NDA 021775 Approval Package — Reviews & Approval Records
Regular price $169.00 USDRegular priceUnit price / perSale price $169.00 USD -
FDA ENTOCORT EC NDA 021324 Approval Package — Reviews & Approval Records
Regular price $229.00 USDRegular priceUnit price / perSale price $229.00 USD -
FDA EPIVIR NDA 020564 Approval Package — Reviews & Approval Records
Regular price $459.00 USDRegular priceUnit price / perSale price $459.00 USD -
FDA EPIVIR NDA 020596 Approval Package — Reviews & Approval Records
Regular price $339.00 USDRegular priceUnit price / perSale price $339.00 USD -
FDA EPYSQLI BLA 761340 Regulatory Review & REMS Collection — Samsung Bioepis
Regular price $399.00 USDRegular priceUnit price / perSale price $399.00 USD -
FDA ERAXIS NDA 021632 Approval Package — Approval Records & Labeling
Regular price $229.00 USDRegular priceUnit price / perSale price $229.00 USD -
FDA ERAXIS NDA 021948 Approval Package — Approval Records & Labeling
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA ESBRIET NDA 022535 Approval Package — Reviews & Approval Records
Regular price $469.00 USDRegular priceUnit price / perSale price $469.00 USD -
FDA ESTRADIOL NDA 020538 Approval Package — Approval Records & Labeling
Regular price $229.00 USDRegular priceUnit price / perSale price $229.00 USD -
FDA ESTRASORB NDA 021371 Approval Package — Approval Records & Labeling
Regular price $169.00 USDRegular priceUnit price / perSale price $169.00 USD -
FDA ESTRING NDA 020472 Approval Package — Reviews & Approval Records
Regular price $239.00 USDRegular priceUnit price / perSale price $239.00 USD -
FDA EVISTA NDA 020815 Approval Package — Reviews & Approval Records
Regular price $169.00 USDRegular priceUnit price / perSale price $169.00 USD -
FDA EXALGO NDA 021217 Approval Package — Reviews & Approval Records
Regular price $229.00 USDRegular priceUnit price / perSale price $229.00 USD -
FDA EXELON NDA 020823 Approval Package — Reviews & Approval Records
Regular price $229.00 USDRegular priceUnit price / perSale price $229.00 USD -
FDA EXTINA NDA 021738 Approval Package — Approval Records & Labeling
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA EYLEA BLA 125387 Approval Package — Reviews & Approval Records
Regular price $479.00 USDRegular priceUnit price / perSale price $479.00 USD -
FDA FABRAZYME BLA 103979 Approval Package — Reviews & Approval Records
Regular price $229.00 USDRegular priceUnit price / perSale price $229.00 USD -
FDA FACTIVE NDA 021158 Approval Package — Approval Records & Labeling
Regular price $229.00 USDRegular priceUnit price / perSale price $229.00 USD -
FDA FAMVIR NDA 020363 Approval Package — Reviews & Approval Records
Regular price $169.00 USDRegular priceUnit price / perSale price $169.00 USD -
FDA FASLODEX NDA 021344 Approval Package — Reviews & Approval Records
Regular price $459.00 USDRegular priceUnit price / perSale price $459.00 USD -
FDA FCN 002035: Chemistry and Toxicology Review Memos and Correspondence
Regular price $282.43 USDRegular priceUnit price / perSale price $282.43 USD -
FDA FCN 1805; Submitted by Solvay Specialty Polymers USA, LLC
Regular price $241.74 USDRegular priceUnit price / perSale price $241.74 USD