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Submission: SPL(r3); Product Listing: Paper. EDR. EDR. ELIPS. ELIPS. ELIPS. EDR. ELIPS. EDR. EDR. CBE & Annual Report. Annual Report. NCE, PAS. CBE. Sponsor. Paper Drug Listing. Initial SPLr3 (COL). Initial SPL r3 (COL). Initial SPLr3 (COL). Final SPLr3

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  1. Submission: SPL(r3); Product Listing: Paper EDR EDR ELIPS ELIPS ELIPS EDR ELIPS EDR EDR CBE & Annual Report Annual Report NCE, PAS CBE Sponsor Paper Drug Listing Initial SPLr3 (COL) Initial SPL r3 (COL) Initial SPLr3 (COL) Final SPLr3 (COL) Paper Drug Listing Final SPLr3 (COL) Process Process FDA Review and respond Paper Paper Review and respond Drug Listing process Application process Drug Listing process Application process Application process Public Labeling on Daily Med Labeling on Daily Med Labeling on Daily Med Labeling on Daily Med plb 7/2008

  2. Submission: SPL(r4); Product Listing: Electronic-phase 1 EDR EDR EDR Labeling on FDA Website Labeling on FDA Website Labeling on FDA Website Labeling on Daily Med Labeling on Daily Med Labeling on Daily Med Labeling on Daily Med NDC Directory NDC Directory NDC Directory NDC Directory Annual Report NCE and PAS CBE Sponsor Initial SPLr4 (COL) Initial SPLr4 (COL) Initial SPL r4 (COL) Final SPLr4 (COL) Initial SPLr4 (COL) Initial SPLr4 (COL) Final SPLr4 (COL) Gateway Gateway Gateway Gateway Process Process FDA ELIST ELIST ELIST ELIST Review and respond Review and respond Drug Listing process Drug Listing process Drug Listing process Drug Listing process Drug Listing process Application process Application process Drug Listing process Drug Listing process Application process Labeling on FDA Website Public plb 7/2008

  3. Submission: SPL(r4); Product Listing: Electronic-phase 2 EDR EDR EDR Labeling on FDA Website Labeling on FDA Website Labeling on FDA Website Labeling on Daily Med Labeling on Daily Med Labeling on Daily Med Labeling on Daily Med NDC Directory NDC Directory NDC Directory NDC Directory Annual Report NCE and PAS CBE Sponsor Hyperlink Hyperlink Initial SPLr4 (COL) Initial SPLr4 (COL) Final SPLr4 (COL) Initial SPLr4 (COL) Final SPLr4 (COL) Gateway Gateway Gateway Gateway Process Process FDA ELIST ELIST ELIST ELIST Review and respond Review and respond Drug Listing process Drug Listing process Drug Listing process Application process Application process Drug Listing process Application process Labeling on FDA Website Public plb 7/2008

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