Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203828
Company: INDCHEMIE HEALTH
Company: INDCHEMIE HEALTH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 07/29/2015 | 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 |
|---|---|---|---|---|---|
| 08/25/2023 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/19/2021 | SUPPL-3 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
NEBIVOLOL HYDROCHLORIDE
TABLET;ORAL; EQ 2.5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BYSTOLIC | NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021742 | ALLERGAN |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 203659 | ANI PHARMS |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 211053 | AUROBINDO PHARMA LTD |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 216568 | BEXIMCO PHARMS USA |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 208717 | CADILA PHARMS LTD |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 203825 | HETERO LABS LTD III |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 203828 | INDCHEMIE HEALTH |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 216172 | MANKIND PHARMA |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 212682 | PRINSTON INC |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 212917 | REYOUNG |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 203966 | TORRENT |
TABLET;ORAL; EQ 5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BYSTOLIC | NEBIVOLOL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021742 | ALLERGAN |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 203659 | ANI PHARMS |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 211053 | AUROBINDO PHARMA LTD |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 216568 | BEXIMCO PHARMS USA |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 208717 | CADILA PHARMS LTD |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 203825 | HETERO LABS LTD III |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 203828 | INDCHEMIE HEALTH |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 216172 | MANKIND PHARMA |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 212682 | PRINSTON INC |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 212917 | REYOUNG |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 203966 | TORRENT |
TABLET;ORAL; EQ 10MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BYSTOLIC | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021742 | ALLERGAN |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 203659 | ANI PHARMS |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 209741 | APOTEX |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 211053 | AUROBINDO PHARMA LTD |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 216568 | BEXIMCO PHARMS USA |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 208717 | CADILA PHARMS LTD |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 203825 | HETERO LABS LTD III |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 203828 | INDCHEMIE HEALTH |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 216172 | MANKIND PHARMA |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 212682 | PRINSTON INC |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 212917 | REYOUNG |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 203966 | TORRENT |
TABLET;ORAL; EQ 20MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BYSTOLIC | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021742 | ALLERGAN |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 203659 | ANI PHARMS |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 209741 | APOTEX |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 211053 | AUROBINDO PHARMA LTD |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 216568 | BEXIMCO PHARMS USA |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 208717 | CADILA PHARMS LTD |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 203825 | HETERO LABS LTD III |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 203828 | INDCHEMIE HEALTH |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 216172 | MANKIND PHARMA |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 212682 | PRINSTON INC |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 212917 | REYOUNG |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 203966 | TORRENT |