Details for New Drug Application (NDA): 206091

NDA 206091 describes ROPIVACAINE HYDROCHLORIDE, which is a drug marketed by Amneal, Caplin, Eugia Pharma, Gland Pharma Ltd, Hikma, Hospira, Inforlife, Kindos, Mylan Labs Ltd, Navinta Llc, Rising, and Somerset Theraps Llc, and is included in fifteen NDAs. It is available from twelve suppliers. Additional details are available on the ROPIVACAINE HYDROCHLORIDE profile page.

The generic ingredient in ROPIVACAINE HYDROCHLORIDE is ropivacaine hydrochloride. There are thirteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ropivacaine hydrochloride profile page.

Summary for 206091

Tradename:	ROPIVACAINE HYDROCHLORIDE
Applicant:	Mylan Labs Ltd
Ingredient:	ropivacaine hydrochloride
Patents:	0

Pharmacology for NDA: 206091

Physiological Effect

Local Anesthesia

Suppliers and Packaging for NDA: 206091

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	SOLUTION;INJECTION	206091	ANDA	Mylan Institutional LLC	67457-798	67457-798-99	10 POUCH in 1 CARTON (67457-798-99) / 1 BAG in 1 POUCH (67457-798-10) / 100 mL in 1 BAG
ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	SOLUTION;INJECTION	206091	ANDA	Mylan Institutional LLC	67457-799	67457-799-99	10 POUCH in 1 CARTON (67457-799-99) / 1 BAG in 1 POUCH (67457-799-20) / 200 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION			Strength	200MG/100ML (2MG/ML)
Approval Date:	Oct 26, 2023	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION			Strength	400MG/200ML (2MG/ML)
Approval Date:	Oct 26, 2023	TE:	AP	RLD:	No

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