Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077431
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EXEMESTANE | EXEMESTANE | 25MG | 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 |
---|---|---|---|---|---|---|---|
04/01/2011 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/077431s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/15/2022 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
08/13/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
08/13/2020 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
07/06/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
07/06/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
08/03/2011 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
EXEMESTANE
TABLET;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AROMASIN | EXEMESTANE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 020753 | PFIZER |
EXEMESTANE | EXEMESTANE | 25MG | TABLET;ORAL | Prescription | No | AB | 211031 | BRECKENRIDGE |
EXEMESTANE | EXEMESTANE | 25MG | TABLET;ORAL | Prescription | No | AB | 210323 | CIPLA |
EXEMESTANE | EXEMESTANE | 25MG | TABLET;ORAL | Prescription | No | AB | 216454 | EUGIA PHARMA |
EXEMESTANE | EXEMESTANE | 25MG | TABLET;ORAL | Prescription | No | AB | 077431 | HIKMA |
EXEMESTANE | EXEMESTANE | 25MG | TABLET;ORAL | Prescription | No | AB | 213547 | QILU |
EXEMESTANE | EXEMESTANE | 25MG | TABLET;ORAL | Prescription | No | AB | 203315 | RISING |
EXEMESTANE | EXEMESTANE | 25MG | TABLET;ORAL | Prescription | No | AB | 209208 | UPSHER SMITH LABS |
EXEMESTANE | EXEMESTANE | 25MG | TABLET;ORAL | Prescription | No | AB | 202602 | ZYDUS PHARMS |