Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200218
Company: ANI PHARMS
Company: ANI PHARMS
| 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 | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 08/30/2013 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/01/2024 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/16/2023 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/18/2023 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/10/2022 | SUPPL-9 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 03/04/2022 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/04/2022 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/25/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/25/2015 | SUPPL-3 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |