Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206006
Company: RISING
Company: RISING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/07/2016 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/16/2023 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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07/18/2023 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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04/14/2022 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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03/04/2022 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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03/04/2022 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL; 500MG;500MG;30MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 206006 | RISING |
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE | 500MG;500MG;30MG | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 202588 | SANDOZ |