Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213358
Company: EUGIA PHARMA
Company: EUGIA PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TAMOXIFEN CITRATE | TAMOXIFEN CITRATE | EQ 10MG BASE | TABLET;ORAL | Prescription | AB | No | No |
TAMOXIFEN CITRATE | TAMOXIFEN CITRATE | EQ 20MG BASE | 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 |
---|---|---|---|---|---|---|---|
08/14/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
TAMOXIFEN CITRATE
TABLET;ORAL; EQ 10MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TAMOXIFEN CITRATE | TAMOXIFEN CITRATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 070929 | ACTAVIS LABS FL INC |
TAMOXIFEN CITRATE | TAMOXIFEN CITRATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 090878 | APOTEX |
TAMOXIFEN CITRATE | TAMOXIFEN CITRATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 075797 | DR REDDYS LABS SA |
TAMOXIFEN CITRATE | TAMOXIFEN CITRATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 213358 | EUGIA PHARMA |
TAMOXIFEN CITRATE | TAMOXIFEN CITRATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 074732 | MYLAN |
TAMOXIFEN CITRATE | TAMOXIFEN CITRATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 206694 | ZYDUS PHARMS |
TABLET;ORAL; EQ 20MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TAMOXIFEN CITRATE | TAMOXIFEN CITRATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 070929 | ACTAVIS LABS FL INC |
TAMOXIFEN CITRATE | TAMOXIFEN CITRATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 090878 | APOTEX |
TAMOXIFEN CITRATE | TAMOXIFEN CITRATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 075797 | DR REDDYS LABS SA |
TAMOXIFEN CITRATE | TAMOXIFEN CITRATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 213358 | EUGIA PHARMA |
TAMOXIFEN CITRATE | TAMOXIFEN CITRATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 074732 | MYLAN |
TAMOXIFEN CITRATE | TAMOXIFEN CITRATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 206694 | ZYDUS PHARMS |