Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202588
Company: SANDOZ INC
Company: SANDOZ INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN | AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE | 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG | CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;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 |
|---|---|---|---|---|---|---|---|
| 03/04/2014 | ORIG-1 | Approval |
Label is not available on this site. |
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN
CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL; 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN | AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE | 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG | CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL | Prescription | No | AB | 202588 | SANDOZ INC |
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