Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075089
Company: APOTEX
Company: APOTEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TICLOPIDINE HYDROCHLORIDE | TICLOPIDINE HYDROCHLORIDE | 250MG | TABLET;ORAL | Prescription | AB | No | 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 |
---|---|---|---|---|---|---|---|
07/01/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75089ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/13/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/21/2001 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
11/21/2001 | SUPPL-5 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
07/05/2002 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
01/27/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
07/11/2000 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/11/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
TICLOPIDINE HYDROCHLORIDE
TABLET;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TICLOPIDINE HYDROCHLORIDE | TICLOPIDINE HYDROCHLORIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 075089 | APOTEX |