Details for New Drug Application (NDA): 216355

NDA 216355 describes PACLITAXEL, which is a drug marketed by Accord Hlthcare, Actavis Totowa, Alembic, Dash Pharms, Fresenius Kabi Usa, Gland, Hikma, Hospira, MSN, Pharmobedient, Pliva Lachema, Sandoz, Teva Pharms, Teva Pharms Usa, Am Regent, Cipla, Hengrui Pharma, Mylan, Shuangcheng, and Teva Pharms Inc, and is included in twenty-two NDAs. It is available from seventeen suppliers. Additional details are available on the PACLITAXEL profile page.

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

Summary for 216355

Tradename:	PACLITAXEL
Applicant:	Shuangcheng
Ingredient:	paclitaxel
Patents:	0

Pharmacology for NDA: 216355

Physiological Effect

Microtubule Inhibition

Medical Subject Heading (MeSH) Categories for 216355

Antineoplastic Agents, Phytogenic

Tubulin Modulators

Suppliers and Packaging for NDA: 216355

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PACLITAXEL	paclitaxel	POWDER;INTRAVENOUS	216355	ANDA	BluePoint Laboratories	68001-651	68001-651-37	1 VIAL, SINGLE-USE in 1 CARTON (68001-651-37) / 20 mL in 1 VIAL, SINGLE-USE
PACLITAXEL	paclitaxel	POWDER;INTRAVENOUS	216355	ANDA	Meitheal Pharmaceuticals Inc.	71288-183	71288-183-50	1 VIAL, SINGLE-USE in 1 CARTON (71288-183-50) / 20 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	100MG/VIAL
Approval Date:	May 15, 2025	TE:	AB	RLD:	No

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