Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076273
Company: DR REDDYS
Company: DR REDDYS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 01/14/2008 | 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 |
|---|---|---|---|---|---|
| 01/09/2023 | SUPPL-33 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/21/2021 | SUPPL-29 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/02/2019 | SUPPL-25 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/02/2019 | SUPPL-24 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/02/2019 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/02/2019 | SUPPL-21 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/02/2019 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/20/2019 | SUPPL-18 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/11/2016 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/11/2016 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/11/2016 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/12/2014 | SUPPL-12 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 06/12/2014 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/18/2012 | SUPPL-8 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 04/18/2012 | SUPPL-7 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/18/2012 | SUPPL-6 | REMS-Modified |
Label is not available on this site. |
||
| 04/18/2012 | SUPPL-5 | REMS-Proposal, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/18/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/18/2010 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/18/2010 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
CLOPIDOGREL BISULFATE
TABLET;ORAL; EQ 75MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 078004 | ACME LABS |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 203632 | ALKEM LABS LTD |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 203751 | AMNEAL PHARMS |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 076274 | APOTEX INC |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 090540 | AUROBINDO PHARMA LTD |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 076273 | DR REDDYS |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 091023 | DR REDDYS LABS LTD |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 205345 | HETERO LABS LTD V |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 202928 | MACLEODS PHARMS LTD |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 215388 | MSN |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 213351 | POLYGEN PHARMS |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 206376 | PRINSTON INC |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 204359 | RISING |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 204165 | SCIEGEN PHARMS INC |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 076999 | TEVA |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 090844 | TORRENT PHARMS LTD |
| PLAVIX | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020839 | SANOFI AVENTIS US |