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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 214129


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NDA 214129 describes CHLORTHALIDONE, which is a drug marketed by Abbott, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Ani Pharms, Appco, Ascot, Barr Labs Inc, Chartwell Rx, Cosette, Dava Pharms Inc, Inventia, Ivax Pharms, Kv Pharm, Mankind Pharma, Mutual Pharm, Mylan, Novast Labs, Pharmobedient, Pioneer Pharms, Purepac Pharm, Sandoz, Sun Pharm Industries, Sunny, Superpharm, Umedica, Unichem, Usl Pharma, Vangard, Warner Chilcott, Watson Labs, and Zydus Pharms, and is included in fifty-eight NDAs. It is available from thirty-five 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. Thirty-six suppliers are listed for this compound. Additional details are available on the chlorthalidone profile page.
Summary for 214129
Tradename:CHLORTHALIDONE
Applicant:Ajanta Pharma Ltd
Ingredient:chlorthalidone
Patents:0
Pharmacology for NDA: 214129
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 214129
Suppliers and Packaging for NDA: 214129
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHLORTHALIDONE chlorthalidone TABLET;ORAL 214129 ANDA Ajanta Pharma USA Inc. 27241-216 27241-216-01 100 TABLET in 1 BOTTLE (27241-216-01)
CHLORTHALIDONE chlorthalidone TABLET;ORAL 214129 ANDA Ajanta Pharma USA Inc. 27241-217 27241-217-01 100 TABLET in 1 BOTTLE (27241-217-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Nov 27, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Nov 27, 2020TE:ABRLD:No

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