Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087294
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG/5ML | SYRUP;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 04/12/1982 | 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 (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/087294s028Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/087294s028Ltr.pdf | |
| 03/30/2016 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/03/2014 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087294Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/087294Orig1s026ltr.pdf | |
| 04/04/2005 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 06/13/2003 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/22/2002 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 12/27/1993 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 02/11/1991 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 02/11/1991 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 02/11/1991 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/19/1990 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 09/08/1993 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 02/07/1989 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1984 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1984 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/1984 | SUPPL-3 | 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 |
|---|---|---|---|---|---|
| 11/08/2016 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/087294s028Lbl.pdf | |
| 06/03/2014 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087294Orig1s026lbl.pdf |
HYDROXYZINE HYDROCHLORIDE
SYRUP;ORAL; 10MG/5ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG/5ML | SYRUP;ORAL | Prescription | Yes | AA | 087294 | CHARTWELL RX |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG/5ML | SYRUP;ORAL | Prescription | No | AA | 201674 | LANNETT CO INC |