Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019429
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FIORINAL W/CODEINE ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/07/2019 SUPPL-43 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019429s043lbl.pdf
10/07/2019 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019429s043lbl.pdf
09/18/2018 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019429s041s042lbl.pdf
09/18/2018 SUPPL-41 REMS - PROPOSAL - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019429s041s042lbl.pdf
08/29/2017 SUPPL-40 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019429s040lbl.pdf
08/29/2017 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019429s040lbl.pdf
12/16/2016 SUPPL-39 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019429s039lbl.pdf
12/16/2016 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019429s039lbl.pdf
12/16/2016 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019429s039lbl.pdf
05/09/2013 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019429s035lbl.pdf
04/08/2008 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019429s023lbl.pdf

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