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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/26/1990 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/16/2016 SUPPL-49 Labeling

Label is not available on this site.

10/07/2019 SUPPL-43 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019429s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019429Orig1s043ltr.pdf
09/18/2018 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019429s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019429Orig1s041s042ltr.pdf
09/18/2018 SUPPL-41 REMS - PROPOSAL - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019429s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019429Orig1s041s042ltr.pdf
08/29/2017 SUPPL-40 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019429s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019429Orig1s040ltr.pdf
12/16/2016 SUPPL-39 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019429s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019429Orig1s039ltr.pdf
11/06/2015 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

11/16/2014 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

05/09/2013 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019429s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019429Orig1s035ltr.pdf
04/08/2008 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019429s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019429s023ltr.pdf
04/26/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/2001 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/30/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/04/2001 SUPPL-16 Labeling

Label is not available on this site.

11/10/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/22/1999 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/12/1996 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/21/1996 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1995 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/2002 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19429slr006ltr.pdf
04/05/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/06/1993 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/06/1993 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/06/1993 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/29/1991 SUPPL-1 Labeling

Label is not available on this site.

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

FIORINAL W/CODEINE

CAPSULE;ORAL; 325MG;50MG;40MG;30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription No AB 203335 MAYNE PHARMA INC
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription No AB 075231 NEXGEN PHARMA INC
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription No AB 074951 STEVENS J
FIORINAL W/CODEINE ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription Yes AB 019429 ALLERGAN

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