Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022421
Company: BOEHRINGER INGELHEIM
Company: BOEHRINGER INGELHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | Yes |
| MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 02/19/2010 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022421lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022421s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022421s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022421s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/12/2021 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022421s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022421Orig1s022ltr.pdf | |
| 01/30/2020 | SUPPL-20 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022421Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022421Orig1s020ltr.pdf | |
| 05/10/2018 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022421s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020667Orig1s036,022421Orig1s017ltr.pdf | |
| 07/28/2016 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022421s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022421Orig1s014ltr.pdf | |
| 01/14/2016 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022421s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022421Orig1s013ltr.pdf | |
| 03/27/2015 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022421s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022421Orig1s010ltr.pdf | |
| 08/23/2013 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/2013 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/2013 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022421s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022421Orig1s007ltr.pdf | |
| 08/31/2012 | SUPPL-6 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022421s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022421Orig1s006ltr.pdf | |
| 05/08/2014 | SUPPL-3 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022421s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022421Orig1s003ltr.pdf | |
| 07/13/2010 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022421s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022421s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/12/2021 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022421s022lbl.pdf | |
| 01/30/2020 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022421Orig1s020lbl.pdf | |
| 01/30/2020 | SUPPL-20 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022421Orig1s020lbl.pdf | |
| 05/10/2018 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022421s017lbl.pdf | |
| 07/28/2016 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022421s014lbl.pdf | |
| 01/14/2016 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022421s013lbl.pdf | |
| 03/27/2015 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022421s010lbl.pdf | |
| 05/08/2014 | SUPPL-3 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022421s003lbl.pdf | |
| 03/01/2013 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022421s007lbl.pdf | |
| 08/31/2012 | SUPPL-6 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022421s006lbl.pdf | |
| 07/13/2010 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022421s001lbl.pdf | |
| 02/19/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022421lbl.pdf |
MIRAPEX ER
TABLET, EXTENDED RELEASE;ORAL; 0.375MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022421 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201963 | ACTAVIS ELIZABETH |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204518 | ALEMBIC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203354 | DR REDDYS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206156 | MACLEODS PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213444 | NOVAST LABS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202353 | SANDOZ |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212797 | XIAMEN LP PHARM CO |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202891 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 0.75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022421 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201963 | ACTAVIS ELIZABETH |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204518 | ALEMBIC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203354 | DR REDDYS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206156 | MACLEODS PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213444 | NOVAST LABS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202353 | SANDOZ |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212797 | XIAMEN LP PHARM CO |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202891 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 1.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022421 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201963 | ACTAVIS ELIZABETH |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204518 | ALEMBIC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203354 | DR REDDYS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206156 | MACLEODS PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213444 | NOVAST LABS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202353 | SANDOZ |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202891 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 3MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022421 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201963 | ACTAVIS ELIZABETH |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204518 | ALEMBIC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203354 | DR REDDYS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206156 | MACLEODS PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213444 | NOVAST LABS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202353 | SANDOZ |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202891 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 4.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022421 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201963 | ACTAVIS ELIZABETH |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204518 | ALEMBIC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203354 | DR REDDYS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206156 | MACLEODS PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213444 | NOVAST LABS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202353 | SANDOZ |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202891 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 2.25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022421 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203615 | ACTAVIS ELIZABETH |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204518 | ALEMBIC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206156 | MACLEODS PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213444 | NOVAST LABS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202891 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 3.75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022421 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203615 | ACTAVIS ELIZABETH |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204518 | ALEMBIC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206156 | MACLEODS PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213444 | NOVAST LABS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202891 | ZYDUS PHARMS |