Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022175
Company: DIGESTIVE CARE INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERTZYE PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 30,250USP UNITS;8,000USP UNITS;28,750USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None Yes No
PERTZYE PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 60,500USP UNITS;16,000USP UNITS;57,500USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None Yes Yes
PERTZYE PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 15,125USP UNITS;4,000USP UNITS;14,375USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None Yes No
PERTZYE PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 90,750USP UNITS;24,000USP UNITS;86,250USP UNITS CAPSULE, DELAYED RELEASE;ORAL Prescription None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/17/2012 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022175s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022175s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022175_pertzye_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022175Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/12/2017 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022175s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022175Orig1s004ltr.pdf
10/06/2016 SUPPL-3 Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022175s003lbl.pdf
01/23/2014 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/12/2017 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022175s004lbl.pdf
10/06/2016 SUPPL-3 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022175s003lbl.pdf
05/17/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022175s000lbl.pdf

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