Drugs@FDA: FDA-Approved Drugs
Company: HARROW EYE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ECONOPRED | PREDNISOLONE ACETATE | 0.125% | SUSPENSION/DROPS;OPHTHALMIC | Discontinued | None | No | 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 |
---|---|---|---|---|---|---|---|
07/10/1973 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
---|---|---|---|---|---|
04/17/2003 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17468slr019,17469slr031_econopred_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17468slr019,17469slr031ltr.pdf | |
08/17/1999 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/07/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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08/04/1998 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/18/1996 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/01/1995 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/01/1995 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/13/1995 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/22/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
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03/02/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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03/12/1986 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/06/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
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05/25/1982 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/24/1979 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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04/06/1977 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/20/1977 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/17/2003 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17468slr019,17469slr031_econopred_lbl.pdf |