Details for New Drug Application (NDA): 219141
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NDA 219141 describes INZIRQO, which is a drug marketed by Novitium Pharma and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the INZIRQO profile page.
The generic ingredient in INZIRQO is hydrochlorothiazide. There are thirty-two drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide profile page.
The generic ingredient in INZIRQO is hydrochlorothiazide. There are thirty-two drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide profile page.
Summary for 219141
| Tradename: | INZIRQO |
| Applicant: | Novitium Pharma |
| Ingredient: | hydrochlorothiazide |
| Patents: | 1 |
Pharmacology for NDA: 219141
| Physiological Effect | Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 219141
Suppliers and Packaging for NDA: 219141
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INZIRQO | hydrochlorothiazide | FOR SUSPENSION;ORAL | 219141 | NDA | ANI Pharmaceuticals, Inc. | 70954-522 | 70954-522-10 | 80 mL in 1 BOTTLE (70954-522-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 10MG/ML | ||||
| Approval Date: | Jan 28, 2025 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 23, 2044 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF EDEMA IN PATIENTS WHO ARE IN NEED OF AN ORAL LIQUID SUSPENSION OF HYDROCHLOROTHIAZIDE | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 23, 2044 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF HYPERTENSION IN PATIENTS WHO ARE IN NEED OF AN ORAL LIQUID SUSPENSION OF HYDROCHLOROTHIAZIDE | ||||||||
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