Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075606
Company: PHARM ASSOC
Company: PHARM ASSOC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE/5ML | SOLUTION;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
08/23/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75606ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/05/2023 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
04/26/2010 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
05/07/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
10/06/2005 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
08/22/2001 | SUPPL-1 | Labeling |
Label is not available on this site. |
NORTRIPTYLINE HYDROCHLORIDE
SOLUTION;ORAL; EQ 10MG BASE/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 075606 | PHARM ASSOC |
NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 217731 | RUBICON |