Drugs@FDA: FDA-Approved Drugs
Company: ROCHE PALO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TICLID | TICLOPIDINE HYDROCHLORIDE | 125MG | TABLET;ORAL | Discontinued | None | No | No |
TICLID | TICLOPIDINE HYDROCHLORIDE | 250MG | TABLET;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 |
---|---|---|---|---|---|---|---|
10/31/1991 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
---|---|---|---|---|---|
11/09/2001 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
06/14/2000 | SUPPL-19 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19979-s019_ticlid.pdf |
04/18/2001 | SUPPL-18 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-979S018_Ticlid_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19979S18ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-879S018_Ticlid.cfm | |
07/28/1999 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
02/03/1998 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/27/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/21/1997 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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02/24/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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10/18/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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01/25/1995 | SUPPL-9 | Labeling |
Label is not available on this site. |
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01/25/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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03/24/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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12/16/1992 | SUPPL-5 | Labeling |
Label is not available on this site. |
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12/10/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
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05/05/1994 | 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 |
---|---|---|---|---|---|
04/18/2001 | SUPPL-18 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-979S018_Ticlid_prntlbl.pdf |