Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019268
Company: PFIZER
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 |
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 |