Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078058
Company: TEVA PHARMS
Company: TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ANASTROZOLE | ANASTROZOLE | 1MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/28/2010 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078058s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/17/2024 | SUPPL-14 | Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 10/28/2020 | SUPPL-11 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 07/23/2015 | SUPPL-8 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/23/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/08/2013 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/22/2011 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
ANASTROZOLE
TABLET;ORAL; 1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ANASTROZOLE | ANASTROZOLE | 1MG | TABLET;ORAL | Prescription | No | AB | 090568 | ACCORD HLTHCARE |
| ANASTROZOLE | ANASTROZOLE | 1MG | TABLET;ORAL | Prescription | No | AB | 206037 | BEIJING YILING |
| ANASTROZOLE | ANASTROZOLE | 1MG | TABLET;ORAL | Prescription | No | AB | 091164 | CIPLA |
| ANASTROZOLE | ANASTROZOLE | 1MG | TABLET;ORAL | Prescription | No | AB | 212434 | EUGIA PHARMA |
| ANASTROZOLE | ANASTROZOLE | 1MG | TABLET;ORAL | Prescription | No | AB | 078944 | KENTON |
| ANASTROZOLE | ANASTROZOLE | 1MG | TABLET;ORAL | Prescription | No | AB | 079220 | NATCO PHARMA LTD |
| ANASTROZOLE | ANASTROZOLE | 1MG | TABLET;ORAL | Prescription | No | AB | 078058 | TEVA PHARMS |
| ANASTROZOLE | ANASTROZOLE | 1MG | TABLET;ORAL | Prescription | No | AB | 078921 | ZYDUS PHARMS USA INC |
| ARIMIDEX | ANASTROZOLE | 1MG | TABLET;ORAL | Prescription | Yes | AB | 020541 | ANI PHARMS |