Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074871
Company: APOTEX INC
Company: APOTEX INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SELEGILINE HYDROCHLORIDE | SELEGILINE HYDROCHLORIDE | 5MG | 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 |
---|---|---|---|---|---|---|---|
06/06/1997 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/01/2009 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
08/18/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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10/20/1998 | SUPPL-3 | Labeling |
Label is not available on this site. |
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06/16/1999 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
06/16/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
SELEGILINE HYDROCHLORIDE
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SELEGILINE HYDROCHLORIDE | SELEGILINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 074871 | APOTEX INC |
SELEGILINE HYDROCHLORIDE | SELEGILINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 074672 | I3 PHARMS |