Drugs@FDA: FDA-Approved Drugs
Company: NOVARTIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VOLTAREN | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/28/1991 | 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 |
---|---|---|---|---|---|
09/13/2012 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020037s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020037Orig1s031ltr.pdf | |
04/08/2011 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020037s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020037s023ltr.pdf | |
10/01/2002 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/09/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/12/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/04/2007 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020037s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020037s014ltr.pdf | |
12/26/2000 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/27/2000 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/05/1998 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/25/1998 | SUPPL-8 | Efficacy-New Indication |
Label is not available on this site. |
||
07/23/1996 | SUPPL-7 | Efficacy-New Indication |
Label is not available on this site. |
||
11/19/1997 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/03/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
03/15/1995 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
03/15/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/08/1992 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
01/09/1992 | 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 |
---|---|---|---|---|---|
09/13/2012 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020037s031lbl.pdf | |
04/08/2011 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020037s023lbl.pdf | |
09/04/2007 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020037s014lbl.pdf |
VOLTAREN
SOLUTION/DROPS;OPHTHALMIC; 0.1%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 077845 | AKORN |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 203383 | ALTAIRE PHARMS INC |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 078792 | BAUSCH AND LOMB |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 078553 | RISING |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 078031 | SANDOZ INC |
VOLTAREN | DICLOFENAC SODIUM | 0.1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 020037 | NOVARTIS |
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