Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091225
Company: NORVIUM BIOSCIENCE
Company: NORVIUM BIOSCIENCE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE;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 |
---|---|---|---|---|---|---|---|
05/31/2011 | 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 |
---|---|---|---|---|---|
09/14/2023 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
09/14/2023 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
09/14/2023 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
09/14/2023 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
09/14/2023 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
09/14/2023 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
03/11/2013 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |