Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075797
Company: MAYNE 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 Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/20/2003 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75797TA.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/01/2006 SUPPL-4 Labeling

Label is not available on this site.

08/18/2005 SUPPL-3 Labeling

Label is not available on this site.

04/20/2005 SUPPL-2 Labeling

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 MAYNE 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 MAYNE 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

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