Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215184
Company: RUBICON
Company: RUBICON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METOLAZONE | METOLAZONE | 2.5MG | TABLET;ORAL | Prescription | AB | No | No |
METOLAZONE | METOLAZONE | 5MG | TABLET;ORAL | Prescription | AB | No | No |
METOLAZONE | METOLAZONE | 10MG | 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 |
---|---|---|---|---|---|---|---|
08/20/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
METOLAZONE
TABLET;ORAL; 2.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METOLAZONE | METOLAZONE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 213251 | ALEMBIC |
METOLAZONE | METOLAZONE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 214799 | BAYSHORE PHARMS LLC |
METOLAZONE | METOLAZONE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 213827 | INNOGENIX |
METOLAZONE | METOLAZONE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 218606 | LEADING |
METOLAZONE | METOLAZONE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 076698 | MYLAN |
METOLAZONE | METOLAZONE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 216216 | NE RX PHARMA |
METOLAZONE | METOLAZONE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 215616 | RENATA |
METOLAZONE | METOLAZONE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 215184 | RUBICON |
METOLAZONE | METOLAZONE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 076732 | SANDOZ |
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METOLAZONE | METOLAZONE | 5MG | TABLET;ORAL | Prescription | No | AB | 213251 | ALEMBIC |
METOLAZONE | METOLAZONE | 5MG | TABLET;ORAL | Prescription | No | AB | 214799 | BAYSHORE PHARMS LLC |
METOLAZONE | METOLAZONE | 5MG | TABLET;ORAL | Prescription | No | AB | 213827 | INNOGENIX |
METOLAZONE | METOLAZONE | 5MG | TABLET;ORAL | Prescription | No | AB | 218606 | LEADING |
METOLAZONE | METOLAZONE | 5MG | TABLET;ORAL | Prescription | No | AB | 076698 | MYLAN |
METOLAZONE | METOLAZONE | 5MG | TABLET;ORAL | Prescription | No | AB | 216216 | NE RX PHARMA |
METOLAZONE | METOLAZONE | 5MG | TABLET;ORAL | Prescription | No | AB | 215616 | RENATA |
METOLAZONE | METOLAZONE | 5MG | TABLET;ORAL | Prescription | No | AB | 215184 | RUBICON |
METOLAZONE | METOLAZONE | 5MG | TABLET;ORAL | Prescription | No | AB | 076466 | SANDOZ |
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METOLAZONE | METOLAZONE | 10MG | TABLET;ORAL | Prescription | No | AB | 213251 | ALEMBIC |
METOLAZONE | METOLAZONE | 10MG | TABLET;ORAL | Prescription | No | AB | 214799 | BAYSHORE PHARMS LLC |
METOLAZONE | METOLAZONE | 10MG | TABLET;ORAL | Prescription | No | AB | 213827 | INNOGENIX |
METOLAZONE | METOLAZONE | 10MG | TABLET;ORAL | Prescription | No | AB | 218606 | LEADING |
METOLAZONE | METOLAZONE | 10MG | TABLET;ORAL | Prescription | No | AB | 076698 | MYLAN |
METOLAZONE | METOLAZONE | 10MG | TABLET;ORAL | Prescription | No | AB | 216216 | NE RX PHARMA |
METOLAZONE | METOLAZONE | 10MG | TABLET;ORAL | Prescription | No | AB | 215616 | RENATA |
METOLAZONE | METOLAZONE | 10MG | TABLET;ORAL | Prescription | No | AB | 215184 | RUBICON |
METOLAZONE | METOLAZONE | 10MG | TABLET;ORAL | Prescription | No | AB | 076466 | SANDOZ |