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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021344

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FASLODEX (FULVESTRANT)
250MG/5ML (50MG/ML)
Marketing Status: Prescription
Active Ingredient: FULVESTRANT
Proprietary Name: FASLODEX
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR
Strength: 250MG/5ML (50MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AO
Application Number: N021344
Product Number: 001
Approval Date: Apr 25, 2002
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information
FASLODEX (FULVESTRANT)
125MG/2.5ML (50MG/ML)
Marketing Status: Discontinued
Active Ingredient: FULVESTRANT
Proprietary Name: FASLODEX
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR
Strength: 125MG/2.5ML (50MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021344
Product Number: 002
Approval Date: Apr 25, 2002
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
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