Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088619
Company: PLIVA
Company: PLIVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/10/1986 | 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-48 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/30/2016 | SUPPL-46 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/29/2016 | SUPPL-45 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/05/2014 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/088617Orig1s043,088618Orig1s043,088619Orig1s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/088617Orig1s043,088618Orig1s043,088619Orig1s044ltr.pdf | |
| 08/05/2008 | SUPPL-31 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/088617s030,088618s028,088619s031lbl.pdf | |
| 02/04/2004 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 01/30/2002 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/06/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/06/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1994 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/1994 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 01/14/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/01/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/11/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/05/2014 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/088617Orig1s043,088618Orig1s043,088619Orig1s044lbl.pdf | |
| 08/05/2008 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/088617s030,088618s028,088619s031lbl.pdf |
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 |