Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208195
Company: YUNG SHIN PHARM
Company: YUNG SHIN PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ENTECAVIR | ENTECAVIR | 0.5MG | TABLET;ORAL | Prescription | AB | No | No |
ENTECAVIR | ENTECAVIR | 1MG | 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 |
---|---|---|---|---|---|---|---|
11/10/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ENTECAVIR
TABLET;ORAL; 0.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BARACLUDE | ENTECAVIR | 0.5MG | TABLET;ORAL | Prescription | Yes | AB | 021797 | BRISTOL MYERS SQUIBB |
ENTECAVIR | ENTECAVIR | 0.5MG | TABLET;ORAL | Prescription | No | AB | 206652 | AMNEAL PHARMS |
ENTECAVIR | ENTECAVIR | 0.5MG | TABLET;ORAL | Prescription | No | AB | 206217 | AUROBINDO PHARMA |
ENTECAVIR | ENTECAVIR | 0.5MG | TABLET;ORAL | Prescription | No | AB | 208721 | BRECKENRIDGE |
ENTECAVIR | ENTECAVIR | 0.5MG | TABLET;ORAL | Prescription | No | AB | 212126 | BRIGHTGENE |
ENTECAVIR | ENTECAVIR | 0.5MG | TABLET;ORAL | Prescription | No | AB | 206872 | CIPLA |
ENTECAVIR | ENTECAVIR | 0.5MG | TABLET;ORAL | Prescription | No | AB | 205740 | HETERO LABS LTD V |
ENTECAVIR | ENTECAVIR | 0.5MG | TABLET;ORAL | Prescription | No | AB | 208782 | PRINSTON INC |
ENTECAVIR | ENTECAVIR | 0.5MG | TABLET;ORAL | Prescription | No | AB | 208195 | YUNG SHIN PHARM |
ENTECAVIR | ENTECAVIR | 0.5MG | TABLET;ORAL | Prescription | No | AB | 206745 | ZYDUS PHARMS |
TABLET;ORAL; 1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BARACLUDE | ENTECAVIR | 1MG | TABLET;ORAL | Prescription | Yes | AB | 021797 | BRISTOL MYERS SQUIBB |
ENTECAVIR | ENTECAVIR | 1MG | TABLET;ORAL | Prescription | No | AB | 206652 | AMNEAL PHARMS |
ENTECAVIR | ENTECAVIR | 1MG | TABLET;ORAL | Prescription | No | AB | 206217 | AUROBINDO PHARMA |
ENTECAVIR | ENTECAVIR | 1MG | TABLET;ORAL | Prescription | No | AB | 208721 | BRECKENRIDGE |
ENTECAVIR | ENTECAVIR | 1MG | TABLET;ORAL | Prescription | No | AB | 212126 | BRIGHTGENE |
ENTECAVIR | ENTECAVIR | 1MG | TABLET;ORAL | Prescription | No | AB | 206872 | CIPLA |
ENTECAVIR | ENTECAVIR | 1MG | TABLET;ORAL | Prescription | No | AB | 205740 | HETERO LABS LTD V |
ENTECAVIR | ENTECAVIR | 1MG | TABLET;ORAL | Prescription | No | AB | 208782 | PRINSTON INC |
ENTECAVIR | ENTECAVIR | 1MG | TABLET;ORAL | Prescription | No | AB | 208195 | YUNG SHIN PHARM |
ENTECAVIR | ENTECAVIR | 1MG | TABLET;ORAL | Prescription | No | AB | 206745 | ZYDUS PHARMS |