Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019183
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARAFATE SUCRALFATE 1GM/10ML SUSPENSION;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
12/16/1993 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019183_biopharm.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/15/2017 SUPPL-19 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019183s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019183Orig1s019ltr.pdf
06/06/2016 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/04/2013 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018333s034,019183s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018333Orig1s034,019183Orig1s016ltr.pdf
12/21/2010 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019183s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019183s014ltr.pdf
04/26/2007 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019183s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019183s011ltr.pdf
02/10/2006 SUPPL-9 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019183s009ltr.pdf
02/08/2000 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/16/1997 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/1997 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/21/1995 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/13/1994 SUPPL-2 Labeling

Label is not available on this site.

04/11/1994 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/15/2017 SUPPL-19 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019183s019lbl.pdf
08/15/2017 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019183s019lbl.pdf
03/04/2013 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018333s034,019183s016lbl.pdf
12/21/2010 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019183s014lbl.pdf
04/26/2007 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019183s011lbl.pdf

CARAFATE

SUSPENSION;ORAL; 1GM/10ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARAFATE SUCRALFATE 1GM/10ML SUSPENSION;ORAL Prescription Yes AB 019183 ALLERGAN
SUCRALFATE SUCRALFATE 1GM/10ML SUSPENSION;ORAL Prescription No AB 209356 AMNEAL PHARMS LLC

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