Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202710
Company: STRIDES PHARMA
Company: STRIDES PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLARITHROMYCIN | CLARITHROMYCIN | 250MG | TABLET;ORAL | Prescription | AB | No | No |
CLARITHROMYCIN | CLARITHROMYCIN | 500MG | 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 |
---|---|---|---|---|---|---|---|
06/10/2013 | 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-6 | Labeling-Package Insert |
Label is not available on this site. |
||
06/28/2023 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
06/28/2023 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
06/28/2023 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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08/28/2014 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
CLARITHROMYCIN
TABLET;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLARITHROMYCIN | CLARITHROMYCIN | 250MG | TABLET;ORAL | Prescription | No | AB | 210459 | ALEMBIC |
CLARITHROMYCIN | CLARITHROMYCIN | 250MG | TABLET;ORAL | Prescription | No | AB | 065489 | AUROBINDO |
CLARITHROMYCIN | CLARITHROMYCIN | 250MG | TABLET;ORAL | Prescription | No | AB | 065384 | CHARTWELL |
CLARITHROMYCIN | CLARITHROMYCIN | 250MG | TABLET;ORAL | Prescription | No | AB | 203584 | HEC PHARM |
CLARITHROMYCIN | CLARITHROMYCIN | 250MG | TABLET;ORAL | Prescription | No | AB | 065144 | SANDOZ |
CLARITHROMYCIN | CLARITHROMYCIN | 250MG | TABLET;ORAL | Prescription | No | AB | 202710 | STRIDES PHARMA |
TABLET;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;ORAL | Prescription | No | AB | 210459 | ALEMBIC |
CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET;ORAL | Prescription | No | AB | 065489 | AUROBINDO |
CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET;ORAL | Prescription | No | AB | 065384 | CHARTWELL |
CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET;ORAL | Prescription | No | AB | 203584 | HEC PHARM |
CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET;ORAL | Prescription | No | AB | 065136 | SANDOZ |
CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET;ORAL | Prescription | No | AB | 202710 | STRIDES PHARMA |