Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090241
Company: HERITAGE PHARMA
Company: HERITAGE PHARMA
| 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 |
|---|---|---|---|---|---|---|---|
| 10/08/2010 | 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 |
|---|---|---|---|---|---|
| 06/14/2011 | SUPPL-1 | Labeling-Container/Carton Labels |
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 |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | Yes | AB | 020667 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 078894 | ALEMBIC PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 090151 | APOTEX INC |
| 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 | 091450 | BRECKENRIDGE PHARM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 090781 | GLENMARK GENERICS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 077724 | HERITAGE PHARMA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 090241 | HERITAGE PHARMA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 202164 | MACLEODS PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 077854 | MYLAN |
| 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 | 207011 | UNICHEM LABS LTD |
| 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 |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | Yes | AB | 020667 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 078894 | ALEMBIC PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 090151 | APOTEX INC |
| 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 | 091450 | BRECKENRIDGE PHARM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 211088 | CSPC OUYI |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 090781 | GLENMARK GENERICS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 077724 | HERITAGE PHARMA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 090241 | HERITAGE PHARMA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 202164 | MACLEODS PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 077854 | MYLAN |
| 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 | 207011 | UNICHEM LABS LTD |
| 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 |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | Yes | AB | 020667 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 078894 | ALEMBIC PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 090151 | APOTEX INC |
| 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 | 091450 | BRECKENRIDGE PHARM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 211088 | CSPC OUYI |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 090781 | GLENMARK GENERICS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 077724 | HERITAGE PHARMA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 090241 | HERITAGE PHARMA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 202164 | MACLEODS PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 077854 | MYLAN |
| 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 | 207011 | UNICHEM LABS LTD |
| 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 |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | Yes | AB | 020667 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 090151 | APOTEX INC |
| 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 | 211088 | CSPC OUYI |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 090781 | GLENMARK GENERICS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 090241 | HERITAGE PHARMA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 090764 | MYLAN |
| 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 | 207011 | UNICHEM LABS LTD |
TABLET;ORAL; 1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | Yes | AB | 020667 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 078894 | ALEMBIC PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 090151 | APOTEX INC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 202633 | AUROBINDO PHARMA LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 091450 | BRECKENRIDGE PHARM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 211088 | CSPC OUYI |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 090781 | GLENMARK GENERICS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 077724 | HERITAGE PHARMA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 090241 | HERITAGE PHARMA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 202164 | MACLEODS PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 077854 | MYLAN |
| 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 | 207011 | UNICHEM LABS LTD |
| 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 |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | Yes | AB | 020667 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 078894 | ALEMBIC PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 090151 | APOTEX INC |
| 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 | 091450 | BRECKENRIDGE PHARM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 211088 | CSPC OUYI |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 090781 | GLENMARK GENERICS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 077724 | HERITAGE PHARMA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 090241 | HERITAGE PHARMA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 202164 | MACLEODS PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 077854 | MYLAN |
| 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 | 207011 | UNICHEM LABS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 078920 | ZYDUS PHARMS USA INC |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English