Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074045
Company: LEADING
Company: LEADING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
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 |
---|---|---|---|---|---|---|---|
04/30/1992 | 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 |
---|---|---|---|---|---|
05/21/2018 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
10/02/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
06/19/2001 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
12/31/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/28/1997 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
07/26/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
NIFEDIPINE
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 | 072556 | ACTAVIS ELIZABETH |
NIFEDIPINE | NIFEDIPINE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 202644 | HERITAGE PHARMA |
NIFEDIPINE | NIFEDIPINE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 074045 | LEADING |