Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216211
Company: RUBICON
Company: RUBICON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 25MG;37.5MG | TABLET;ORAL | Prescription | AB | No | No |
TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 50MG;75MG | 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 |
---|---|---|---|---|---|---|---|
02/23/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
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 |
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 |
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 | 216211 | RUBICON |
TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 50MG;75MG | TABLET;ORAL | Prescription | No | AB | 072011 | SANDOZ |
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 |