Details for New Drug Application (NDA): 021344
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The generic ingredient in FASLODEX is fulvestrant. There are twelve drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the fulvestrant profile page.
Summary for 021344
Tradename: | FASLODEX |
Applicant: | Astrazeneca |
Ingredient: | fulvestrant |
Patents: | 0 |
Pharmacology for NDA: 021344
Mechanism of Action | Estrogen Receptor Antagonists Selective Estrogen Receptor Modulators |
Suppliers and Packaging for NDA: 021344
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FASLODEX | fulvestrant | SOLUTION;INTRAMUSCULAR | 021344 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0720 | 0310-0720-10 | 2 SYRINGE, GLASS in 1 CARTON (0310-0720-10) / 5 mL in 1 SYRINGE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR | Strength | 250MG/5ML (50MG/ML) | ||||
Approval Date: | Apr 25, 2002 | TE: | AO | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR | Strength | 125MG/2.5ML (50MG/ML) | ||||
Approval Date: | Apr 25, 2002 | TE: | RLD: | Yes |
Expired US Patents for NDA 021344
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca | FASLODEX | fulvestrant | SOLUTION;INTRAMUSCULAR | 021344-001 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | FASLODEX | fulvestrant | SOLUTION;INTRAMUSCULAR | 021344-001 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | FASLODEX | fulvestrant | SOLUTION;INTRAMUSCULAR | 021344-001 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | FASLODEX | fulvestrant | SOLUTION;INTRAMUSCULAR | 021344-001 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | FASLODEX | fulvestrant | SOLUTION;INTRAMUSCULAR | 021344-001 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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