Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017118
Company: ENDO PHARMS
Company: ENDO PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SYMMETREL | AMANTADINE HYDROCHLORIDE | 50MG/5ML | SYRUP; ORAL | 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 |
---|---|---|---|---|---|---|---|
07/20/1976 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | 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 |
---|---|---|---|---|---|
12/31/2008 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017118s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017118s019ltr.pdf | |
09/04/2003 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018101s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17118slr017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/017118_s017_Symmetrel_syrup.pdf | |
01/11/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/29/1999 | SUPPL-13 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
03/31/1999 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
04/11/1996 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/03/1986 | SUPPL-7 | Labeling |
Label is not available on this site. |
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10/27/1978 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/02/1977 | 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 |
---|---|---|---|---|---|
12/31/2008 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017118s019lbl.pdf | |
09/04/2003 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018101s009lbl.pdf |