Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200181
Company: NOVEL LABS INC
Company: NOVEL LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHENELZINE SULFATE | PHENELZINE SULFATE | EQ 15MG BASE | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
12/08/2010 | 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 |
---|---|---|---|---|---|
07/17/2014 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
PHENELZINE SULFATE
TABLET;ORAL; EQ 15MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NARDIL | PHENELZINE SULFATE | EQ 15MG BASE | TABLET;ORAL | Prescription | Yes | AB | 011909 | PARKE DAVIS |
PHENELZINE SULFATE | PHENELZINE SULFATE | EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 200181 | NOVEL LABS INC |