Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205927
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRASUGREL | PRASUGREL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| PRASUGREL | PRASUGREL HYDROCHLORIDE | EQ 10MG 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 |
|---|---|---|---|---|---|---|---|
| 07/12/2017 | ORIG-1 | Approval | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205927Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205927Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/24/2020 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/12/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205927Orig1s000lbl.pdf |
PRASUGREL
TABLET;ORAL; EQ 5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EFFIENT | PRASUGREL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | Yes | AB | 022307 | DAIICHI SANKYO INC |
| PRASUGREL | PRASUGREL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 205987 | ACCORD HLTHCARE |
| PRASUGREL | PRASUGREL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 205888 | AUROBINDO PHARMA LTD |
| PRASUGREL | PRASUGREL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 206021 | HEC PHARM |
| PRASUGREL | PRASUGREL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 205927 | MYLAN |
| PRASUGREL | PRASUGREL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 205897 | PANACEA |
| PRASUGREL | PRASUGREL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 205790 | USPHARMA WINDLAS |
TABLET;ORAL; EQ 10MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EFFIENT | PRASUGREL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | Yes | AB | 022307 | DAIICHI SANKYO INC |
| PRASUGREL | PRASUGREL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 205987 | ACCORD HLTHCARE |
| PRASUGREL | PRASUGREL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 205888 | AUROBINDO PHARMA LTD |
| PRASUGREL | PRASUGREL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 206021 | HEC PHARM |
| PRASUGREL | PRASUGREL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 205927 | MYLAN |
| PRASUGREL | PRASUGREL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 205897 | PANACEA |
| PRASUGREL | PRASUGREL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 205790 | USPHARMA WINDLAS |
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