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Last Updated: August 3, 2021

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Details for New Drug Application (NDA): 205935

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NDA 205935 describes FULVESTRANT, which is a drug marketed by Accord Hlthcare, Amneal, Auromedics Pharma, Chia Tai Tianqing, Dr Reddys, Glenmark Pharms Inc, Hbt Labs Inc, Sagent Pharms Inc, Sandoz Inc, Fresenius Kabi Usa, and Teva Pharms Usa Inc, and is included in eleven NDAs. It is available from thirteen suppliers. There are three patents protecting this drug. Additional details are available on the FULVESTRANT profile page.

The generic ingredient in FULVESTRANT is fulvestrant. There are twelve drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the fulvestrant profile page.
Summary for 205935
Applicant:Sandoz Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 205935
Suppliers and Packaging for NDA: 205935
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FULVESTRANT fulvestrant INJECTABLE;INTRAMUSCULAR 205935 ANDA Sandoz Inc 0781-3079 0781-3079-12 2 SYRINGE, GLASS in 1 CARTON (0781-3079-12) > 5 mL in 1 SYRINGE, GLASS (0781-3079-01)
FULVESTRANT fulvestrant INJECTABLE;INTRAMUSCULAR 205935 ANDA Northstar RxLLC 16714-118 16714-118-02 2 SYRINGE, GLASS in 1 CARTON (16714-118-02) > 5 mL in 1 SYRINGE, GLASS (16714-118-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULARStrength50MG/ML
Approval Date:May 14, 2019TE:AORLD:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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