Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077169
Company: ELITE LABS INC
Company: ELITE LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ISRADIPINE | ISRADIPINE | 2.5MG | CAPSULE;ORAL | Prescription | AB | No | No |
ISRADIPINE | ISRADIPINE | 5MG | 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 |
---|---|---|---|---|---|---|---|
04/24/2006 | ORIG-1 | Approval |
Label is not available on this site. |
ISRADIPINE
CAPSULE;ORAL; 2.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ISRADIPINE | ISRADIPINE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 077169 | ELITE LABS INC |
ISRADIPINE | ISRADIPINE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 077317 | WATSON LABS TEVA |
CAPSULE;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ISRADIPINE | ISRADIPINE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 077169 | ELITE LABS INC |
ISRADIPINE | ISRADIPINE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 077317 | WATSON LABS TEVA |