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Last Updated: August 14, 2020

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Details for New Drug Application (NDA): 089286

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NDA 089286 describes CHLORTHALIDONE, which is a drug marketed by Abbott, Alkem Labs Ltd, Amneal Pharms Co, Ani Pharms Inc, Arise, Ascot, Barr Labs Inc, Cosette, Dava Pharms Inc, Ivax Pharms, Kv Pharm, Mutual Pharm, Mylan, Pioneer Pharms, Purepac Pharm, Riconpharma Llc, Sandoz, Sun Pharm Industries, Superpharm, Umedica Labs Pvt Ltd, Unichem Labs Ltd, Usl Pharma, Vangard, Vistapharm, Warner Chilcott, Watson Labs, and Zydus Pharms, and is included in fifty-one NDAs. It is available from twenty-four suppliers. Additional details are available on the CHLORTHALIDONE profile page.

The generic ingredient in CHLORTHALIDONE is chlorthalidone. There are twenty-one drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the chlorthalidone profile page.
Summary for 089286
Tradename:CHLORTHALIDONE
Applicant:Sun Pharm Industries
Ingredient:chlorthalidone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 089286
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 089286
Suppliers and Packaging for NDA: 089286
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHLORTHALIDONE chlorthalidone TABLET;ORAL 089286 ANDA Major Pharmaceuticals 0904-6900 0904-6900-04 30 BLISTER PACK in 1 CARTON (0904-6900-04) > 1 TABLET in 1 BLISTER PACK
CHLORTHALIDONE chlorthalidone TABLET;ORAL 089286 ANDA Major Pharmaceuticals 0904-6900 0904-6900-61 100 BLISTER PACK in 1 CARTON (0904-6900-61) > 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jul 21, 1986TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jul 21, 1986TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

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