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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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/30/1995 ORIG-1 Approval Type 3 - New Dosage Form 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
07/07/2020 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020411Orig1s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020411Orig1s031ltr.pdf
05/26/2010 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020411s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020411s027ltr.pdf
11/28/2006 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020411s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020411s023ltr.pdf
01/25/2002 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
12/21/2001 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
11/06/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
04/13/2000 SUPPL-16 Labeling

Label is not available on this site.
06/30/2000 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
02/11/2000 SUPPL-14 Labeling

Label is not available on this site.
06/27/2000 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
11/05/1999 SUPPL-11 Labeling

Label is not available on this site.
08/31/1999 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/19/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
02/24/1999 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
02/03/1998 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
12/24/1997 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
08/24/1999 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
12/18/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
04/04/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
08/29/1995 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.
02/22/1996 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
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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