Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019129
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MAXZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 50MG;75MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MAXZIDE-25 | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 25MG;37.5MG | TABLET;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 10/22/1984 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-56 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019129s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019129Orig1s056ltr.pdf | |
| 05/11/2015 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/2011 | SUPPL-43 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019129s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019129s043ltr.pdf | |
| 02/02/2001 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/16/1999 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/10/1997 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 09/12/1996 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/01/1992 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 06/06/1991 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/06/1989 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 07/21/1988 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1988 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 05/13/1988 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1988 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/28/1987 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/1987 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/1987 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1987 | SUPPL-15 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 02/09/1990 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 04/14/1987 | SUPPL-13 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 07/08/1986 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 01/27/1986 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/13/1988 | SUPPL-8 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 10/08/1985 | SUPPL-7 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/16/1985 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/10/1985 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/26/1985 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/01/1985 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/03/1985 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019129s056lbl.pdf | |
| 03/20/2011 | SUPPL-43 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019129s043lbl.pdf |
MAXZIDE
TABLET;ORAL; 50MG;75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MAXZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 50MG;75MG | TABLET;ORAL | Prescription | Yes | AB | 019129 | AUROBINDO PHARMA USA |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 50MG;75MG | TABLET;ORAL | Prescription | No | AB | 071251 | APOTEX INC |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 50MG;75MG | TABLET;ORAL | Prescription | No | AB | 072011 | CHARTWELL RX |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 50MG;75MG | TABLET;ORAL | Prescription | No | AB | 216211 | RUBICON RESEARCH |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 50MG;75MG | TABLET;ORAL | Prescription | No | AB | 071851 | WATSON LABS |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 50MG;75MG | TABLET;ORAL | Prescription | No | AB | 208360 | ZYDUS PHARMS |
MAXZIDE-25
TABLET;ORAL; 25MG;37.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MAXZIDE-25 | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 25MG;37.5MG | TABLET;ORAL | Prescription | Yes | AB | 019129 | AUROBINDO PHARMA USA |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 25MG;37.5MG | TABLET;ORAL | Prescription | No | AB | 071251 | APOTEX INC |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 25MG;37.5MG | TABLET;ORAL | Prescription | No | AB | 216211 | RUBICON RESEARCH |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 25MG;37.5MG | TABLET;ORAL | Prescription | No | AB | 073281 | SANDOZ |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 25MG;37.5MG | TABLET;ORAL | Prescription | No | AB | 073449 | WATSON LABS |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 25MG;37.5MG | TABLET;ORAL | Prescription | No | AB | 208360 | ZYDUS PHARMS |