Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203983
Company: JUBILANT GENERICS
Company: JUBILANT GENERICS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FELODIPINE | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
FELODIPINE | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
FELODIPINE | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
08/19/2016 | ORIG-1 | Approval |
Label is not available on this site. |
FELODIPINE
TABLET, EXTENDED RELEASE;ORAL; 2.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FELODIPINE | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203417 | AUROBINDO PHARMA LTD |
FELODIPINE | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090365 | GLENMARK GENERICS |
FELODIPINE | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201964 | HERITAGE PHARMS INC |
FELODIPINE | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203983 | JUBILANT GENERICS |
FELODIPINE | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203032 | ORCHID HLTHCARE |
FELODIPINE | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091200 | SUN PHARM INDS LTD |
FELODIPINE | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075896 | SUN PHARM INDUSTRIES |
FELODIPINE | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202170 | TORRENT PHARMS LTD |
FELODIPINE | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200815 | VINTAGE PHARMS LLC |
FELODIPINE | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210847 | YILING |
FELODIPINE | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204800 | YUNG SHIN PHARM |
TABLET, EXTENDED RELEASE;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FELODIPINE | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203417 | AUROBINDO PHARMA LTD |
FELODIPINE | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090365 | GLENMARK GENERICS |
FELODIPINE | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201964 | HERITAGE PHARMS INC |
FELODIPINE | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203983 | JUBILANT GENERICS |
FELODIPINE | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203032 | ORCHID HLTHCARE |
FELODIPINE | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091200 | SUN PHARM INDS LTD |
FELODIPINE | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075896 | SUN PHARM INDUSTRIES |
FELODIPINE | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202170 | TORRENT PHARMS LTD |
FELODIPINE | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200815 | VINTAGE PHARMS LLC |
FELODIPINE | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210847 | YILING |
FELODIPINE | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204800 | YUNG SHIN PHARM |
TABLET, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FELODIPINE | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203417 | AUROBINDO PHARMA LTD |
FELODIPINE | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090365 | GLENMARK GENERICS |
FELODIPINE | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201964 | HERITAGE PHARMS INC |
FELODIPINE | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203983 | JUBILANT GENERICS |
FELODIPINE | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203032 | ORCHID HLTHCARE |
FELODIPINE | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091200 | SUN PHARM INDS LTD |
FELODIPINE | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075896 | SUN PHARM INDUSTRIES |
FELODIPINE | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202170 | TORRENT PHARMS LTD |
FELODIPINE | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200815 | VINTAGE PHARMS LLC |
FELODIPINE | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210847 | YILING |
FELODIPINE | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204800 | YUNG SHIN PHARM |
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