Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203855
Company: SCIEGEN PHARMS INC
Company: SCIEGEN PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | AB | No | No |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | AB | No | No |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | AB | No | No |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | AB | No | No |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | AB | No | No |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/28/2014 | 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 |
|---|---|---|---|---|---|
| 05/05/2022 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/05/2022 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/05/2022 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/05/2022 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/11/2016 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/26/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
PRAMIPEXOLE DIHYDROCHLORIDE
TABLET;ORAL; 0.125MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 202633 | AUROBINDO PHARMA LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 090781 | GLENMARK PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 203855 | SCIEGEN PHARMS INC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 202702 | STRIDES PHARMA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 090865 | TORRENT PHARMS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 090151 | ZENNOVA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 078920 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 0.25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 202633 | AUROBINDO PHARMA LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 090781 | GLENMARK PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 211088 | RISING |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 203855 | SCIEGEN PHARMS INC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 202702 | STRIDES PHARMA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 090865 | TORRENT PHARMS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 090151 | ZENNOVA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 078920 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 0.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 202633 | AUROBINDO PHARMA LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 090781 | GLENMARK PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 211088 | RISING |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 203855 | SCIEGEN PHARMS INC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 202702 | STRIDES PHARMA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 090865 | TORRENT PHARMS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 090151 | ZENNOVA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 078920 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 0.75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 202633 | AUROBINDO PHARMA LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 090781 | GLENMARK PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 211088 | RISING |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 203855 | SCIEGEN PHARMS INC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 202702 | STRIDES PHARMA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 090865 | TORRENT PHARMS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 090151 | ZENNOVA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 078920 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 202633 | AUROBINDO PHARMA LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 090781 | GLENMARK PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 211088 | RISING |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 203855 | SCIEGEN PHARMS INC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 202702 | STRIDES PHARMA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 090865 | TORRENT PHARMS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 090151 | ZENNOVA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 078920 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 1.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 202633 | AUROBINDO PHARMA LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 090781 | GLENMARK PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 211088 | RISING |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 203855 | SCIEGEN PHARMS INC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 202702 | STRIDES PHARMA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 090865 | TORRENT PHARMS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 090151 | ZENNOVA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 078920 | ZYDUS PHARMS USA INC |