Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076070
Company: VALEANT PHARMS NORTH
Company: VALEANT PHARMS NORTH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB1 | 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 |
---|---|---|---|---|---|---|---|
08/16/2002 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076070.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/26/2012 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
NIFEDIPINE
TABLET, EXTENDED RELEASE;ORAL; 90MG
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 213361 | AUROBINDO PHARMA |
NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 202987 | NOVAST LABS |
NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 076070 | VALEANT PHARMS NORTH |
NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 210184 | ZYDUS PHARMS |