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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 202489


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NDA 202489 describes TINIDAZOLE, which is a drug marketed by Chartwell Rx, Edenbridge Pharms, Hikma, and Thinq Pharm-cro Pvt, and is included in four NDAs. It is available from six suppliers. Additional details are available on the TINIDAZOLE profile page.

The generic ingredient in TINIDAZOLE is tinidazole. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tinidazole profile page.
Summary for 202489
Tradename:TINIDAZOLE
Applicant:Thinq Pharm-cro Pvt
Ingredient:tinidazole
Patents:0
Pharmacology for NDA: 202489
Medical Subject Heading (MeSH) Categories for 202489
Suppliers and Packaging for NDA: 202489
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TINIDAZOLE tinidazole TABLET;ORAL 202489 ANDA Rising Pharma Holdings, Inc. 64980-426 64980-426-02 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-426-02)
TINIDAZOLE tinidazole TABLET;ORAL 202489 ANDA Rising Pharma Holdings, Inc. 64980-427 64980-427-12 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Oct 9, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Oct 9, 2013TE:ABRLD:No

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