Details for New Drug Application (NDA): 202462
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NDA 202462 describes CHLOROTHIAZIDE SODIUM, which is a drug marketed by Am Regent, Fresenius Kabi Usa, Gland Pharma Ltd, Rk Pharma, Sagent Pharms Inc, and Sun Pharm, and is included in six NDAs. It is available from five suppliers. Additional details are available on the CHLOROTHIAZIDE SODIUM profile page.
The generic ingredient in CHLOROTHIAZIDE SODIUM is chlorothiazide sodium. There are forty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the chlorothiazide sodium profile page.
The generic ingredient in CHLOROTHIAZIDE SODIUM is chlorothiazide sodium. There are forty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the chlorothiazide sodium profile page.
Summary for 202462
| Tradename: | CHLOROTHIAZIDE SODIUM |
| Applicant: | Sagent Pharms Inc |
| Ingredient: | chlorothiazide sodium |
| Patents: | 0 |
Pharmacology for NDA: 202462
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 202462
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHLOROTHIAZIDE SODIUM | chlorothiazide sodium | INJECTABLE;INJECTION | 202462 | ANDA | Sagent Pharmaceuticals | 25021-305 | 25021-305-66 | 1 VIAL in 1 CARTON (25021-305-66) / 18 mL in 1 VIAL |
| CHLOROTHIAZIDE SODIUM | chlorothiazide sodium | INJECTABLE;INJECTION | 202462 | ANDA | Sagent Pharmaceuticals | 25021-305 | 25021-305-20 | 1 VIAL in 1 CARTON (25021-305-20) / 18 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | May 29, 2015 | TE: | AP | RLD: | No | ||||
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