Drugs@FDA: FDA-Approved Drugs
Company: ALLERGAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PRED-G | GENTAMICIN SULFATE; PREDNISOLONE ACETATE | EQ 0.3% BASE;1% | SUSPENSION/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 |
---|---|---|---|---|---|---|---|
06/10/1988 | ORIG-1 | Approval | Type 4 - New Combination | 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 |
---|---|---|---|---|---|
06/07/2018 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050586s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050586Orig1s032ltr.pdf | |
03/20/2017 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050586s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050586Orig1s031ltr.pdf | |
12/20/2005 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050586s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050586s025_s026ltr.pdf | |
12/20/2005 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050586s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050586s025_s026ltr.pdf | |
04/12/2002 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/04/2001 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/28/2001 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/12/2001 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/02/2000 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/26/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/08/1998 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/01/1997 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/02/1996 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/03/1995 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/30/1991 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
03/07/1994 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/31/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/21/1989 | SUPPL-5 | Efficacy-New Indication |
Label is not available on this site. |
||
07/29/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/29/1988 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
11/30/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/07/2018 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050586s032lbl.pdf | |
03/20/2017 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050586s031lbl.pdf | |
12/20/2005 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050586s025s026lbl.pdf | |
12/20/2005 | SUPPL-25 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050586s025s026lbl.pdf |