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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009402
Company: ENDO OPERATIONS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DELESTROGEN ESTRADIOL VALERATE 10MG/ML INJECTABLE;INJECTION Prescription AO Yes Yes
DELESTROGEN ESTRADIOL VALERATE 40MG/ML INJECTABLE;INJECTION Discontinued None Yes No
DELESTROGEN ESTRADIOL VALERATE 20MG/ML INJECTABLE;INJECTION Prescription AO Yes 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
07/15/1954 ORIG-1 Approval UNKNOWN

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/15/2024 SUPPL-63 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/009402s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/009402Orig1s063ltr.pdf
02/16/2022 SUPPL-60 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/009402Orig1s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/009402Orig1s060ltr.pdf
11/01/2017 SUPPL-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009402s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/009402Orig1s052ltr.pdf
03/10/2016 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.
10/20/2015 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.
08/11/2015 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.
10/11/2007 SUPPL-41 Labeling-Package Insert, Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/009402s041ltr.pdf
07/26/2004 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/09402s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/09402s040ltr.pdf
12/12/2003 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09402slr037_delestrogen_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09402slr037ltr.pdf
07/17/2002 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.
12/12/2003 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09402slr037_delestrogen_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09402slr037ltr.pdf
06/17/1998 SUPPL-36 Labeling

Label is not available on this site.
01/12/1990 SUPPL-35 Labeling

Label is not available on this site.
05/05/1989 SUPPL-34 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/02/1989 SUPPL-33 Labeling

Label is not available on this site.
12/28/1987 SUPPL-31 Labeling

Label is not available on this site.
09/11/1987 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.
03/02/1989 SUPPL-29 Labeling

Label is not available on this site.
05/05/1986 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.
01/15/1985 SUPPL-26 Labeling

Label is not available on this site.
11/26/1984 SUPPL-25 Labeling

Label is not available on this site.
11/16/1984 SUPPL-24 Labeling

Label is not available on this site.
06/01/1984 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
07/31/1985 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
03/19/1984 SUPPL-21 Labeling

Label is not available on this site.
07/18/1983 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
09/07/1982 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
02/15/2024 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/009402s063lbl.pdf
02/16/2022 SUPPL-60 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/009402Orig1s060lbl.pdf
02/16/2022 SUPPL-60 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/009402Orig1s060lbl.pdf
11/01/2017 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009402s052lbl.pdf
07/26/2004 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/09402s040lbl.pdf
12/12/2003 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09402slr037_delestrogen_lbl.pdf
12/12/2003 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09402slr037_delestrogen_lbl.pdf

DELESTROGEN

INJECTABLE;INJECTION; 10MG/ML
TE Code = AO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DELESTROGEN ESTRADIOL VALERATE 10MG/ML INJECTABLE;INJECTION Prescription Yes AO 009402 ENDO OPERATIONS
ESTRADIOL VALERATE ESTRADIOL VALERATE 10MG/ML INJECTABLE;INJECTION Prescription No AO 203723 HIKMA
ESTRADIOL VALERATE ESTRADIOL VALERATE 10MG/ML INJECTABLE;INJECTION Prescription No AO 216656 XIROMED

INJECTABLE;INJECTION; 20MG/ML
TE Code = AO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DELESTROGEN ESTRADIOL VALERATE 20MG/ML INJECTABLE;INJECTION Prescription Yes AO 009402 ENDO OPERATIONS
ESTRADIOL VALERATE ESTRADIOL VALERATE 20MG/ML INJECTABLE;INJECTION Prescription No AO 090920 AM REGENT
ESTRADIOL VALERATE ESTRADIOL VALERATE 20MG/ML INJECTABLE;INJECTION Prescription No AO 203723 HIKMA
ESTRADIOL VALERATE ESTRADIOL VALERATE 20MG/ML INJECTABLE;INJECTION Prescription No AO 216656 XIROMED
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