Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040640
Company: STRIDES PHARMA
Company: STRIDES PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRANYLCYPROMINE SULFATE | TRANYLCYPROMINE SULFATE | EQ 10MG 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 |
---|---|---|---|---|---|---|---|
06/29/2006 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/040640s000LTR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/19/2010 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
12/12/2007 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
12/12/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
TRANYLCYPROMINE SULFATE
TABLET;ORAL; EQ 10MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PARNATE | TRANYLCYPROMINE SULFATE | EQ 10MG BASE | TABLET;ORAL | Prescription | Yes | AB | 012342 | CONCORDIA |
TRANYLCYPROMINE SULFATE | TRANYLCYPROMINE SULFATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 213503 | CROSSMEDIKA SA |
TRANYLCYPROMINE SULFATE | TRANYLCYPROMINE SULFATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 206856 | NOVITIUM PHARMA |
TRANYLCYPROMINE SULFATE | TRANYLCYPROMINE SULFATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 040640 | STRIDES PHARMA |