Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075321
Company: APOTEX
Company: APOTEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SELEGILINE HYDROCHLORIDE | SELEGILINE HYDROCHLORIDE | 5MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
12/04/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75321ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/31/2011 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
11/30/2010 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
08/06/2010 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
06/16/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
SELEGILINE HYDROCHLORIDE
CAPSULE;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 | CAPSULE;ORAL | Prescription | No | AB | 075321 | APOTEX |
SELEGILINE HYDROCHLORIDE | SELEGILINE HYDROCHLORIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 075352 | NOVITIUM PHARMA |
SELEGILINE HYDROCHLORIDE | SELEGILINE HYDROCHLORIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 206803 | RISING |