Drugs@FDA: FDA-Approved Drugs
Company: PFIZER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROSTIN E2 | DINOPROSTONE | 20MG | SUPPOSITORY;VAGINAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
08/23/1977 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/05/2017 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017810s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017810Orig1s019ltr.pdf | |
05/29/2013 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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08/05/1997 | SUPPL-16 | Labeling |
Label is not available on this site. |
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11/19/1997 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/19/1997 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/01/1991 | SUPPL-13 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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05/08/1992 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/22/1988 | SUPPL-11 | Labeling |
Label is not available on this site. |
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06/23/1987 | SUPPL-10 | Labeling |
Label is not available on this site. |
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09/08/1986 | SUPPL-9 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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09/29/1986 | SUPPL-8 | Labeling |
Label is not available on this site. |
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03/02/1982 | SUPPL-7 | Labeling |
Label is not available on this site. |
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03/20/1980 | SUPPL-6 | Labeling |
Label is not available on this site. |
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03/12/1979 | SUPPL-4 | Labeling |
Label is not available on this site. |
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08/04/1978 | SUPPL-3 | Labeling |
Label is not available on this site. |
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01/18/1978 | SUPPL-2 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/05/2017 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017810s019lbl.pdf |