Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087871
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | AB | No | No |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | AB | No | No |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/20/1982 | 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 |
|---|---|---|---|---|---|
| 11/08/2016 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/30/2016 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/03/2014 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/10/2000 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/21/1995 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/14/1988 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 04/25/1988 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/25/1988 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1985 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/1984 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
HYDROXYZINE HYDROCHLORIDE
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040808 | AMNEAL PHARM |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 087871 | AUROBINDO PHARMA LTD |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040804 | CHARTWELL RX |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040604 | EPIC PHARMA LLC |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 217652 | GRAVITI PHARMS |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 204279 | HERITAGE PHARMA |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040805 | HETERO LABS LTD III |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040786 | KVK TECH |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040840 | NORTHSTAR HLTHCARE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 207121 | NUVO PHARMS INC |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 088619 | PLIVA |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040580 | PRINSTON INC |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 040808 | AMNEAL PHARM |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 087871 | AUROBINDO PHARMA LTD |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 040804 | CHARTWELL RX |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 040604 | EPIC PHARMA LLC |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 217652 | GRAVITI PHARMS |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 204279 | HERITAGE PHARMA |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 040805 | HETERO LABS LTD III |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 040786 | KVK TECH |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 040840 | NORTHSTAR HLTHCARE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 040841 | NORTHSTAR HLTHCARE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 207121 | NUVO PHARMS INC |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 088617 | PLIVA |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 040580 | PRINSTON INC |
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040808 | AMNEAL PHARM |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 087871 | AUROBINDO PHARMA LTD |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040804 | CHARTWELL RX |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040604 | EPIC PHARMA LLC |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 217652 | GRAVITI PHARMS |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 204279 | HERITAGE PHARMA |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040805 | HETERO LABS LTD III |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040786 | KVK TECH |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040840 | NORTHSTAR HLTHCARE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040842 | NORTHSTAR HLTHCARE |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 207121 | NUVO PHARMS INC |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 088618 | PLIVA |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040580 | PRINSTON INC |