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Last Updated: September 20, 2020

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Details for New Drug Application (NDA): 202044

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NDA 202044 describes TINIDAZOLE, which is a drug marketed by Edenbridge Pharms, Hikma, Novel Labs Inc, and Unique Pharm Labs, and is included in four NDAs. It is available from five 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. Five suppliers are listed for this compound. Additional details are available on the tinidazole profile page.
Summary for 202044
Applicant:Novel Labs Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 202044
Medical Subject Heading (MeSH) Categories for 202044
Suppliers and Packaging for NDA: 202044
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TINIDAZOLE tinidazole TABLET;ORAL 202044 ANDA Lupin Pharmaceuticals,Inc. 43386-550 43386-550-04 40 TABLET in 1 BOTTLE (43386-550-04)
TINIDAZOLE tinidazole TABLET;ORAL 202044 ANDA Lupin Pharmaceuticals,Inc. 43386-551 43386-551-02 20 TABLET in 1 BOTTLE (43386-551-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Apr 30, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Apr 30, 2012TE:ABRLD:No

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