Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020907
Company: AMNEAL PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACTIVELLA ESTRADIOL; NORETHINDRONE ACETATE 1MG;0.5MG TABLET;ORAL Prescription AB Yes Yes
ACTIVELLA ESTRADIOL; NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET;ORAL Prescription AB Yes 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
11/18/1998 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20907lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20907ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20907.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/01/2017 SUPPL-19 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020907s019lbl.pdf
05/27/2016 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/12/2015 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/08/2013 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020907s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020907Orig1s013ltr.pdf
12/28/2006 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020907s009s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020907s009, s011ltr.pdf
12/28/2006 SUPPL-9 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020907s009s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020907s009, s011ltr.pdf
07/26/2004 SUPPL-7 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020907_S007.pdf
09/13/2002 SUPPL-6 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020907_S006.pdf
06/30/2005 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020907s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020907s005ltr.pdf
11/14/2000 SUPPL-4 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020907_S004.pdf
04/11/2000 SUPPL-3 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020907_S003.pdf
02/10/2000 SUPPL-2 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020907_S002.pdf
11/03/1999 SUPPL-1 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020907_S001.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/01/2017 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020907s019lbl.pdf
10/08/2013 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020907s013lbl.pdf
12/28/2006 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020907s009s011lbl.pdf
12/28/2006 SUPPL-9 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020907s009s011lbl.pdf
06/30/2005 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020907s005lbl.pdf
11/18/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20907lbl.pdf

ACTIVELLA

TABLET;ORAL; 1MG;0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTIVELLA ESTRADIOL; NORETHINDRONE ACETATE 1MG;0.5MG TABLET;ORAL Prescription Yes AB 020907 AMNEAL PHARMS LLC
AMABELZ ESTRADIOL; NORETHINDRONE ACETATE 1MG;0.5MG TABLET;ORAL Prescription No AB 203339 LUPIN LTD
ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE 1MG;0.5MG TABLET;ORAL Prescription No AB 079193 BARR
ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE 1MG;0.5MG TABLET;ORAL Prescription No AB 078324 BRECKENRIDGE PHARM
ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE 1MG;0.5MG TABLET;ORAL Prescription No AB 207261 MYLAN LABS LTD

TABLET;ORAL; 0.5MG;0.1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTIVELLA ESTRADIOL; NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET;ORAL Prescription Yes AB 020907 AMNEAL PHARMS LLC
AMABELZ ESTRADIOL; NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET;ORAL Prescription No AB 203339 LUPIN LTD
ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET;ORAL Prescription No AB 078324 BRECKENRIDGE PHARM
ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET;ORAL Prescription No AB 207261 MYLAN LABS LTD
ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET;ORAL Prescription No AB 200747 TEVA PHARMS USA

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