Drugs@FDA: FDA-Approved Drugs
Company: PFIZER
| 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 | PFIZER |
| MISOPROSTOL | MISOPROSTOL | 0.2MG | TABLET;ORAL | Prescription | No | AB | 076095 | ANI PHARMS |
| MISOPROSTOL | MISOPROSTOL | 0.2MG | TABLET;ORAL | Prescription | No | AB | 216872 | MICRO LABS |
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 | PFIZER |
| MISOPROSTOL | MISOPROSTOL | 0.1MG | TABLET;ORAL | Prescription | No | AB | 076095 | ANI PHARMS |
| MISOPROSTOL | MISOPROSTOL | 0.1MG | TABLET;ORAL | Prescription | No | AB | 216872 | MICRO LABS |