Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020706
Company: NOVARTIS
Company: NOVARTIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EMADINE | EMEDASTINE DIFUMARATE | 0.05% | 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 |
---|---|---|---|---|---|---|---|
12/29/1997 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020706_emadine_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/12/2003 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20706slr011_emadine_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20706slr011ltr.pdf | |
12/04/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/13/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/16/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/18/2000 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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12/20/1999 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/17/1999 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/28/1999 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/05/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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08/04/1998 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/04/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/12/2003 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20706slr011_emadine_lbl.pdf |