Details for New Drug Application (NDA): 218647
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NDA 218647 describes HEMICLOR, which is a drug marketed by Prm Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the HEMICLOR profile page.
The generic ingredient in HEMICLOR is chlorthalidone. There are twenty-one drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the chlorthalidone profile page.
The generic ingredient in HEMICLOR is chlorthalidone. There are twenty-one drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the chlorthalidone profile page.
Summary for 218647
| Tradename: | HEMICLOR |
| Applicant: | Prm Pharma |
| Ingredient: | chlorthalidone |
| Patents: | 0 |
Pharmacology for NDA: 218647
| Physiological Effect | Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 218647
Suppliers and Packaging for NDA: 218647
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HEMICLOR | chlorthalidone | TABLET;ORAL | 218647 | NDA | Ingenus Pharmaceuticals, LLC | 50742-285 | 50742-285-30 | 30 TABLET in 1 BOTTLE (50742-285-30) |
| HEMICLOR | chlorthalidone | TABLET;ORAL | 218647 | NDA | Ingenus Pharmaceuticals, LLC | 50742-285 | 50742-285-90 | 90 TABLET in 1 BOTTLE (50742-285-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
| Approval Date: | Mar 17, 2025 | TE: | RLD: | Yes | |||||
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