Drugs@FDA: FDA-Approved Drugs
Company: ALLERGAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OPHTHETIC | PROPARACAINE HYDROCHLORIDE | 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
01/23/1961 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
03/19/2003 | SUPPL-40 | Labeling |
Label is not available on this site. |
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04/12/2002 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/20/2002 | SUPPL-37 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/12583s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12583s028,s037LTR.pdf | |
04/12/2001 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/12/2001 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/02/2000 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/17/1997 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/18/1997 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/17/1997 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/05/1995 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/20/2002 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/12583s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12583s028,s037LTR.pdf | |
08/03/1995 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/04/1993 | SUPPL-26 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
02/05/1990 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/05/1990 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/20/1989 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/13/1989 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/21/1987 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
05/21/1982 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/21/1982 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/22/1980 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/04/1979 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/14/1977 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/23/1976 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
09/10/1976 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/23/1976 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
09/10/1976 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/17/1975 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
07/01/1975 | SUPPL-5 | 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 |
---|---|---|---|---|---|
06/20/2002 | SUPPL-37 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/12583s037lbl.pdf |
06/20/2002 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/12583s037lbl.pdf |