Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090462
Company: SIGMAPHARM LABS LLC
Company: SIGMAPHARM LABS LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROTRIPTYLINE HYDROCHLORIDE | PROTRIPTYLINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | AB | No | No |
PROTRIPTYLINE HYDROCHLORIDE | PROTRIPTYLINE HYDROCHLORIDE | 10MG | 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 |
---|---|---|---|---|---|---|---|
05/03/2010 | 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-3 | Labeling-Package Insert |
Label is not available on this site. |
PROTRIPTYLINE HYDROCHLORIDE
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROTRIPTYLINE HYDROCHLORIDE | PROTRIPTYLINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 202220 | EPIC PHARMA LLC |
PROTRIPTYLINE HYDROCHLORIDE | PROTRIPTYLINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 078913 | HIKMA |
PROTRIPTYLINE HYDROCHLORIDE | PROTRIPTYLINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090462 | SIGMAPHARM LABS LLC |
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROTRIPTYLINE HYDROCHLORIDE | PROTRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 202220 | EPIC PHARMA LLC |
PROTRIPTYLINE HYDROCHLORIDE | PROTRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 078913 | HIKMA |
PROTRIPTYLINE HYDROCHLORIDE | PROTRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 090462 | SIGMAPHARM LABS LLC |