Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208987
Company: SUNSHINE
Company: SUNSHINE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
07/09/2018 | 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-14 | Labeling-Package Insert |
Label is not available on this site. |
||
08/17/2023 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
08/17/2023 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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08/17/2023 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
CLARITHROMYCIN
TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 065145 | ACTAVIS LABS FL INC |
CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 065154 | DR REDDYS LABS SA |
CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203243 | NOSTRUM LABS INC |
CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208987 | SUNSHINE |