Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208832
Company: AMNEAL PHARMS CO
Company: AMNEAL PHARMS CO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NADOLOL | NADOLOL | 20MG | TABLET;ORAL | Prescription | AB | No | No |
NADOLOL | NADOLOL | 40MG | TABLET;ORAL | Prescription | AB | No | No |
NADOLOL | NADOLOL | 80MG | 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 |
---|---|---|---|---|---|---|---|
06/02/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
NADOLOL
TABLET;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CORGARD | NADOLOL | 20MG | TABLET;ORAL | Prescription | Yes | AB | 018063 | USWM |
NADOLOL | NADOLOL | 20MG | TABLET;ORAL | Prescription | No | AB | 208832 | AMNEAL PHARMS CO |
NADOLOL | NADOLOL | 20MG | TABLET;ORAL | Prescription | No | AB | 210955 | BEXIMCO PHARMS USA |
NADOLOL | NADOLOL | 20MG | TABLET;ORAL | Prescription | No | AB | 074229 | HERITAGE PHARMA |
NADOLOL | NADOLOL | 20MG | TABLET;ORAL | Prescription | No | AB | 203455 | INVAGEN PHARMS |
NADOLOL | NADOLOL | 20MG | TABLET;ORAL | Prescription | No | AB | 209309 | LUPIN LTD |
NADOLOL | NADOLOL | 20MG | TABLET;ORAL | Prescription | No | AB | 074172 | MYLAN |
NADOLOL | NADOLOL | 20MG | TABLET;ORAL | Prescription | No | AB | 210786 | NOVAST LABS |
NADOLOL | NADOLOL | 20MG | TABLET;ORAL | Prescription | No | AB | 074501 | SANDOZ |
NADOLOL | NADOLOL | 20MG | TABLET;ORAL | Prescription | No | AB | 207761 | ZYDUS PHARMS |
TABLET;ORAL; 40MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CORGARD | NADOLOL | 40MG | TABLET;ORAL | Prescription | Yes | AB | 018063 | USWM |
NADOLOL | NADOLOL | 40MG | TABLET;ORAL | Prescription | No | AB | 208832 | AMNEAL PHARMS CO |
NADOLOL | NADOLOL | 40MG | TABLET;ORAL | Prescription | No | AB | 201893 | AUROBINDO PHARMA LTD |
NADOLOL | NADOLOL | 40MG | TABLET;ORAL | Prescription | No | AB | 210955 | BEXIMCO PHARMS USA |
NADOLOL | NADOLOL | 40MG | TABLET;ORAL | Prescription | No | AB | 074229 | HERITAGE PHARMA |
NADOLOL | NADOLOL | 40MG | TABLET;ORAL | Prescription | No | AB | 203455 | INVAGEN PHARMS |
NADOLOL | NADOLOL | 40MG | TABLET;ORAL | Prescription | No | AB | 209309 | LUPIN LTD |
NADOLOL | NADOLOL | 40MG | TABLET;ORAL | Prescription | No | AB | 074172 | MYLAN |
NADOLOL | NADOLOL | 40MG | TABLET;ORAL | Prescription | No | AB | 210786 | NOVAST LABS |
NADOLOL | NADOLOL | 40MG | TABLET;ORAL | Prescription | No | AB | 074501 | SANDOZ |
NADOLOL | NADOLOL | 40MG | TABLET;ORAL | Prescription | No | AB | 207761 | ZYDUS PHARMS |
TABLET;ORAL; 80MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CORGARD | NADOLOL | 80MG | TABLET;ORAL | Prescription | Yes | AB | 018063 | USWM |
NADOLOL | NADOLOL | 80MG | TABLET;ORAL | Prescription | No | AB | 208832 | AMNEAL PHARMS CO |
NADOLOL | NADOLOL | 80MG | TABLET;ORAL | Prescription | No | AB | 201893 | AUROBINDO PHARMA LTD |
NADOLOL | NADOLOL | 80MG | TABLET;ORAL | Prescription | No | AB | 210955 | BEXIMCO PHARMS USA |
NADOLOL | NADOLOL | 80MG | TABLET;ORAL | Prescription | No | AB | 074255 | HERITAGE PHARMA |
NADOLOL | NADOLOL | 80MG | TABLET;ORAL | Prescription | No | AB | 203455 | INVAGEN PHARMS |
NADOLOL | NADOLOL | 80MG | TABLET;ORAL | Prescription | No | AB | 209309 | LUPIN LTD |
NADOLOL | NADOLOL | 80MG | TABLET;ORAL | Prescription | No | AB | 074172 | MYLAN |
NADOLOL | NADOLOL | 80MG | TABLET;ORAL | Prescription | No | AB | 210786 | NOVAST LABS |
NADOLOL | NADOLOL | 80MG | TABLET;ORAL | Prescription | No | AB | 074501 | SANDOZ |
NADOLOL | NADOLOL | 80MG | TABLET;ORAL | Prescription | No | AB | 207761 | ZYDUS PHARMS |
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