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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009402
Company: PAR STERILE PRODUCTS
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 Prescription AO Yes Yes
DELESTROGEN ESTRADIOL VALERATE 20MG/ML INJECTABLE;INJECTION Prescription AO Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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
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