Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 075896
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| 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 |
|---|---|---|---|---|---|---|---|
| 11/02/2004 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75896ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075896_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/13/2013 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/13/2013 | SUPPL-13 | Labeling-Package Insert |
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 PHARM LTD |
| 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 PHARM LTD |
| 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 PHARM LTD |
| FELODIPINE | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204800 | YUNG SHIN PHARM |
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