You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 22, 2024

Details for New Drug Application (NDA): 208681

✉ Email this page to a colleague

« Back to Dashboard

NDA 208681 describes METRONIDAZOLE, which is a drug marketed by Able, Alembic, Chartwell Rx, Cosette, Fougera Pharms, Zydus Lifesciences, Encube, Taro, Glenmark Pharms Ltd, Padagis Israel, Solaris Pharma Corp, Abbott, Abraxis Pharm, Hikma, Intl Medication, Watson Labs, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Cadila, Cadila Pharms Ltd, Chartwell Molecules, Flamingo Pharms, Fosun Pharma, Halsey, Heritage Pharms Inc, Innogenix, Ivax Sub Teva Pharms, LNK, Lupin Ltd, Mutual Pharm, Pliva, Strides Pharma, Superpharm, Teva Pharms Usa, Unichem, Watson Labs Inc, Amneal, Baxter Hlthcare Corp, Gland Pharma Ltd, Hospira, Inforlife, and Rising, and is included in sixty-eight NDAs. It is available from fifty-four suppliers. Additional details are available on the METRONIDAZOLE profile page.

The generic ingredient in METRONIDAZOLE is metronidazole hydrochloride. There are eighteen drug master file entries for this compound. Additional details are available on the metronidazole hydrochloride profile page.

Summary for 208681

Tradename:	METRONIDAZOLE
Applicant:	Alembic
Ingredient:	metronidazole
Patents:	0

Pharmacology for NDA: 208681

Medical Subject Heading (MeSH) Categories for 208681

Anti-Infective Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 208681

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METRONIDAZOLE	metronidazole	TABLET;ORAL	208681	ANDA	Alembic Labs LLC	15955-388	15955-388-01	100 TABLET in 1 BOTTLE (15955-388-01)
METRONIDAZOLE	metronidazole	TABLET;ORAL	208681	ANDA	Alembic Labs LLC	15955-388	15955-388-05	500 TABLET in 1 BOTTLE (15955-388-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Jun 20, 2017	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jun 20, 2017	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.