Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020232
Company: ACTAVIS LABS UT INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FIORICET W/ CODEINE ACETAMINOPHEN; 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-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020232s044lbl.pdf
09/18/2018 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020232s042s043lbl.pdf
09/18/2018 SUPPL-42 REMS - PROPOSAL - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020232s042s043lbl.pdf
08/29/2017 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020232s041lbl.pdf
12/16/2016 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020232s040lbl.pdf
12/16/2016 SUPPL-40 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020232s040lbl.pdf
12/16/2016 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020232s040lbl.pdf
10/18/2013 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020232s036lbl.pdf
05/09/2013 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020232s035lbl.pdf
06/22/2011 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020232s033lbl.pdf
03/21/2008 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020232s021lbl.pdf

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