Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090289
Company: TEVA PHARMS
Company: TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LETROZOLE | LETROZOLE | 2.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/03/2011 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/19/2019 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/19/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/13/2015 | SUPPL-3 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/13/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
LETROZOLE
TABLET;ORAL; 2.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FEMARA | LETROZOLE | 2.5MG | TABLET;ORAL | Prescription | Yes | AB | 020726 | NOVARTIS PHARMS |
| LETROZOLE | LETROZOLE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 090934 | ACCORD HLTHCARE |
| LETROZOLE | LETROZOLE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 091303 | APOTEX INC |
| LETROZOLE | LETROZOLE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 205869 | BEIJING YILING |
| LETROZOLE | LETROZOLE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 091191 | DR REDDYS LABS LTD |
| LETROZOLE | LETROZOLE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 211717 | EUGIA PHARMA |
| LETROZOLE | LETROZOLE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 201804 | INDICUS PHARMA |
| LETROZOLE | LETROZOLE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 200161 | NATCO PHARMA LTD |
| LETROZOLE | LETROZOLE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 090289 | TEVA PHARMS |
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