Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087068
Company: OXFORD PHARMS
Company: OXFORD PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/05/1980 | 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 |
|---|---|---|---|---|---|
| 10/23/2023 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/20/2020 | SUPPL-22 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/18/2005 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 05/07/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/11/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/30/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/1995 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 08/04/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1993 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/10/1993 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 07/11/1994 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/26/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/09/1990 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/20/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 11/15/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 08/15/1983 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1983 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
HYDROCHLOROTHIAZIDE
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 202556 | ACCORD HLTHCARE |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040780 | AUROBINDO PHARMA |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 085182 | HERITAGE PHARMS |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040807 | IPCA LABS LTD |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 083177 | IVAX SUB TEVA PHARMS |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040702 | LEADING |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 087068 | OXFORD PHARMS |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040412 | PRINSTON INC |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 203018 | SCIEGEN PHARMS INC |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040907 | UNICHEM |