Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210058
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMBRISENTAN | AMBRISENTAN | 5MG | TABLET;ORAL | Prescription | AB | No | No |
AMBRISENTAN | AMBRISENTAN | 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 |
---|---|---|---|---|---|---|---|
03/28/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210058Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/08/2021 | SUPPL-6 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
12/22/2020 | SUPPL-5 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
02/14/2020 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
04/20/2020 | SUPPL-3 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
12/09/2019 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
12/09/2019 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
AMBRISENTAN
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMBRISENTAN | AMBRISENTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 210701 | APOTEX |
AMBRISENTAN | AMBRISENTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 216531 | AUROBINDO PHARMA |
AMBRISENTAN | AMBRISENTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 210715 | CIPLA |
AMBRISENTAN | AMBRISENTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 208441 | MYLAN |
AMBRISENTAN | AMBRISENTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 208354 | SIGMAPHARM LABS LLC |
AMBRISENTAN | AMBRISENTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 210784 | SUN PHARM |
AMBRISENTAN | AMBRISENTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 208252 | WATSON LABS INC |
AMBRISENTAN | AMBRISENTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 210058 | ZYDUS PHARMS |
LETAIRIS | AMBRISENTAN | 5MG | TABLET;ORAL | Prescription | Yes | AB | 022081 | GILEAD |
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMBRISENTAN | AMBRISENTAN | 10MG | TABLET;ORAL | Prescription | No | AB | 210701 | APOTEX |
AMBRISENTAN | AMBRISENTAN | 10MG | TABLET;ORAL | Prescription | No | AB | 216531 | AUROBINDO PHARMA |
AMBRISENTAN | AMBRISENTAN | 10MG | TABLET;ORAL | Prescription | No | AB | 210715 | CIPLA |
AMBRISENTAN | AMBRISENTAN | 10MG | TABLET;ORAL | Prescription | No | AB | 208441 | MYLAN |
AMBRISENTAN | AMBRISENTAN | 10MG | TABLET;ORAL | Prescription | No | AB | 208354 | SIGMAPHARM LABS LLC |
AMBRISENTAN | AMBRISENTAN | 10MG | TABLET;ORAL | Prescription | No | AB | 210784 | SUN PHARM |
AMBRISENTAN | AMBRISENTAN | 10MG | TABLET;ORAL | Prescription | No | AB | 208252 | WATSON LABS INC |
AMBRISENTAN | AMBRISENTAN | 10MG | TABLET;ORAL | Prescription | No | AB | 210058 | ZYDUS PHARMS |
LETAIRIS | AMBRISENTAN | 10MG | TABLET;ORAL | Prescription | Yes | AB | 022081 | GILEAD |