Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200161
Company: NATCO PHARMA LTD
Company: NATCO PHARMA LTD
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 |
---|---|---|---|---|---|
08/20/2020 | SUPPL-6 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
08/07/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
08/07/2020 | SUPPL-1 | 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 | 205869 | BEIJING YILING |
LETROZOLE | LETROZOLE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 091191 | CARNEGIE |
LETROZOLE | LETROZOLE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 211717 | EUGIA 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 |