Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203807
Company: DR REDDYS LABS SA
Company: DR REDDYS LABS SA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOZAPINE | CLOZAPINE | 25MG | TABLET;ORAL | Discontinued | None | No | No |
| CLOZAPINE | CLOZAPINE | 100MG | TABLET;ORAL | Discontinued | None | No | No |
| CLOZAPINE | CLOZAPINE | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| CLOZAPINE | CLOZAPINE | 200MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 09/17/2015 | 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 |
|---|---|---|---|---|---|
| 11/10/2021 | SUPPL-14 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 07/29/2021 | SUPPL-13 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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| 02/18/2021 | SUPPL-10 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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| 01/16/2019 | SUPPL-6 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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| 05/10/2017 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/10/2017 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/10/2017 | SUPPL-2 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/10/2017 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |