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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020411
Company: FERRING PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CERVIDIL DINOPROSTONE 10MG INSERT, EXTENDED RELEASE;VAGINAL Prescription None Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/07/2020 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020411Orig1s031lbl.pdf
05/26/2010 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020411s027lbl.pdf
11/28/2006 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020411s023lbl.pdf
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