Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201893
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|
| 09/16/2015 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201893Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/01/2019 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
NADOLOL
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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