Details for New Drug Application (NDA): 085182
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NDA 085182 describes HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic Pharms Ltd, Apotex, Aurobindo Pharma, Chartwell Molecular, Hikma Intl Pharms, Ipca Labs Ltd, Ivax Sub Teva Pharms, Jubilant Cadista, Norvium Bioscience, Prinston Inc, Sciegen Pharms Inc, Sun Pharm Inds Inc, Unichem, Morton Grove, Roxane, Abc Holding, Accord Hlthcare, Actavis Elizabeth, Alra, Ascot, Aurolife Pharma Llc, Barr, Chartwell Rx, Dava Pharms Inc, Elkins Sinn, Heather, Heritage, Impax Labs, Inwood Labs, Lannett Co Inc, Leading, Mast Mm, Mylan, Oxford Pharms, Pvt Form, Solvay, Sun Pharm Industries, Superpharm, Teva, Usl Pharma, Vangard, Warner Chilcott, Watson Labs, Watson Labs Teva, West Ward, Whiteworth Town Plsn, Alkem Labs Ltd, and Pharmeral, and is included in one hundred and eleven NDAs. It is available from forty-five suppliers. Additional details are available on the HYDROCHLOROTHIAZIDE profile page.
The generic ingredient in HYDROCHLOROTHIAZIDE is hydralazine hydrochloride; hydrochlorothiazide; reserpine. There are twenty-one drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide; reserpine profile page.
The generic ingredient in HYDROCHLOROTHIAZIDE is hydralazine hydrochloride; hydrochlorothiazide; reserpine. There are twenty-one drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide; reserpine profile page.
Summary for 085182
| Tradename: | HYDROCHLOROTHIAZIDE |
| Applicant: | Heritage |
| Ingredient: | hydrochlorothiazide |
| Patents: | 0 |
Pharmacology for NDA: 085182
| Physiological Effect | Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 085182
Suppliers and Packaging for NDA: 085182
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROCHLOROTHIAZIDE | hydrochlorothiazide | TABLET;ORAL | 085182 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8450 | 0615-8450-05 | 15 TABLET in 1 BLISTER PACK (0615-8450-05) |
| HYDROCHLOROTHIAZIDE | hydrochlorothiazide | TABLET;ORAL | 085182 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8450 | 0615-8450-39 | 30 TABLET in 1 BLISTER PACK (0615-8450-39) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
| Approval Date: | May 2, 2023 | TE: | AB | RLD: | No | ||||
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