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Generated: April 30, 2017

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Details for New Drug Application (NDA): 020262

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NDA 020262 describes TAXOL, which is a drug marketed by Hq Spclt Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the TAXOL profile page.

The generic ingredient in TAXOL is paclitaxel. There are sixty-seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.

Summary for NDA: 020262

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 020262

Physiological EffectMicrotubule Inhibition

Suppliers and Packaging for NDA: 020262

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TAXOL
paclitaxel
INJECTABLE;INJECTION 020262 NDA WG Critical Care, LLC 44567-504 44567-504-01 1 VIAL, MULTI-DOSE in 1 CARTON (44567-504-01) > 5 mL in 1 VIAL, MULTI-DOSE
TAXOL
paclitaxel
INJECTABLE;INJECTION 020262 NDA WG Critical Care, LLC 44567-505 44567-505-01 1 VIAL, MULTI-DOSE in 1 CARTON (44567-505-01) > 16.7 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength6MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 29, 1992TE:APRLD:Yes

Expired Orange Book Patents for NDA: 020262

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hq Spclt Pharma
TAXOL
paclitaxel
INJECTABLE;INJECTION020262-001Dec 29, 19925,670,537► Subscribe
Hq Spclt Pharma
TAXOL
paclitaxel
INJECTABLE;INJECTION020262-001Dec 29, 19926,096,331► Subscribe
Hq Spclt Pharma
TAXOL
paclitaxel
INJECTABLE;INJECTION020262-001Dec 29, 19925,496,804► Subscribe
Hq Spclt Pharma
TAXOL
paclitaxel
INJECTABLE;INJECTION020262-001Dec 29, 19926,150,398► Subscribe
Hq Spclt Pharma
TAXOL
paclitaxel
INJECTABLE;INJECTION020262-001Dec 29, 19925,641,803► Subscribe
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