Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079220
Company: NATCO PHARMA LTD
Company: NATCO PHARMA LTD
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/2010/079220s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/06/2014 | SUPPL-1 | 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 |