Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202644
Company: HERITAGE PHARMA
Company: HERITAGE PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NIFEDIPINE | NIFEDIPINE | 10MG | CAPSULE;ORAL | Prescription | AB | No | No |
NIFEDIPINE | NIFEDIPINE | 20MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
04/25/2013 | 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 |
---|---|---|---|---|---|
01/26/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
12/11/2014 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
12/11/2014 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
NIFEDIPINE
CAPSULE;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NIFEDIPINE | NIFEDIPINE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 072781 | ACELLA |
NIFEDIPINE | NIFEDIPINE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 072579 | ACTAVIS ELIZABETH |
NIFEDIPINE | NIFEDIPINE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 202644 | HERITAGE PHARMA |
NIFEDIPINE | NIFEDIPINE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 073250 | VELZEN PHARMA PVT |
PROCARDIA | NIFEDIPINE | 10MG | CAPSULE;ORAL | Prescription | Yes | AB | 018482 | PFIZER |
CAPSULE;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NIFEDIPINE | NIFEDIPINE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 202644 | HERITAGE PHARMA |
NIFEDIPINE | NIFEDIPINE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 074045 | VELZEN PHARMA PVT |