Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLARITHROMYCIN | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | No | No |
CLARITHROMYCIN | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION;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 |
---|---|---|---|---|---|---|---|
09/04/2007 | 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 |
---|---|---|---|---|---|
08/16/2023 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
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02/14/2023 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
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02/14/2023 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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02/14/2023 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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05/28/2015 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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05/28/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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05/28/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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04/18/2013 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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12/22/2010 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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03/04/2009 | SUPPL-6 | Labeling |
Label is not available on this site. |
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09/18/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
CLARITHROMYCIN
FOR SUSPENSION;ORAL; 125MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLARITHROMYCIN | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065283 | SANDOZ |
FOR SUSPENSION;ORAL; 250MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLARITHROMYCIN | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065283 | SANDOZ |