Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078004
Company: ACME LABS
Company: ACME LABS
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 |
---|---|---|---|---|---|---|---|
05/17/2012 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/078004Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/20/2020 | SUPPL-3 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
05/20/2020 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
06/02/2016 | SUPPL-1 | 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 | 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 PHARMA |
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 |