Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019268
Company: GD SEARLE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYTOTEC MISOPROSTOL 0.2MG TABLET;ORAL Prescription AB Yes Yes
CYTOTEC MISOPROSTOL 0.1MG TABLET;ORAL Prescription AB 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
12/27/1988 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019268Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/28/2018 SUPPL-51 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019268s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019268Orig1s051ltr.pdf
12/19/2016 SUPPL-49 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019268Orig1s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019268Orig1s049ltr.pdf
02/08/2013 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

11/19/2012 SUPPL-47 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019268s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019268Orig1s047ltr.pdf
09/11/2009 SUPPL-41 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019268s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019268s041ltr.pdf
08/13/2003 SUPPL-40 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19268slr040ltr.pdf
08/13/2003 SUPPL-39 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19268slr039ltr.pdf
07/01/2002 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/2002 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19268slr037.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19268s037ltr.pdf
10/19/2000 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

10/19/2000 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

01/07/2000 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

08/11/1999 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/22/2000 SUPPL-31 Labeling

Label is not available on this site.

12/03/1998 SUPPL-30 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/15/1998 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

10/15/1998 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

07/14/1998 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/1997 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/10/1997 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1996 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/13/1997 SUPPL-23 Labeling

Label is not available on this site.

06/11/1996 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1994 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/10/1993 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/28/1992 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/29/1991 SUPPL-15 Labeling

Label is not available on this site.

04/23/1991 SUPPL-14 Labeling

Label is not available on this site.

09/06/1990 SUPPL-13 Labeling

Label is not available on this site.

09/21/1990 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/05/1990 SUPPL-10 Labeling

Label is not available on this site.

06/21/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/05/1990 SUPPL-8 Labeling

Label is not available on this site.

05/09/1990 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/16/1990 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/27/1989 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/18/1989 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/08/1989 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
02/28/2018 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019268s051lbl.pdf
12/19/2016 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019268Orig1s049lbl.pdf
11/19/2012 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019268s047lbl.pdf
11/19/2012 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019268s047lbl.pdf
09/11/2009 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019268s041lbl.pdf
04/17/2002 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19268slr037.pdf

CYTOTEC

TABLET;ORAL; 0.2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYTOTEC MISOPROSTOL 0.2MG TABLET;ORAL Prescription Yes AB 019268 GD SEARLE LLC
MISOPROSTOL MISOPROSTOL 0.2MG TABLET;ORAL Prescription No AB 076095 ANI PHARMS INC
MISOPROSTOL MISOPROSTOL 0.2MG TABLET;ORAL Prescription No AB 091667 NOVEL LABS INC
MISOPROSTOL MISOPROSTOL 0.2MG TABLET;ORAL Prescription No AB 210201 ZYDUS PHARMS

TABLET;ORAL; 0.1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYTOTEC MISOPROSTOL 0.1MG TABLET;ORAL Prescription Yes AB 019268 GD SEARLE LLC
MISOPROSTOL MISOPROSTOL 0.1MG TABLET;ORAL Prescription No AB 076095 ANI PHARMS INC
MISOPROSTOL MISOPROSTOL 0.1MG TABLET;ORAL Prescription No AB 091667 NOVEL LABS INC
MISOPROSTOL MISOPROSTOL 0.1MG TABLET;ORAL Prescription No AB 210201 ZYDUS PHARMS

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