Details for New Drug Application (NDA): 091546
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NDA 091546 describes CHLOROTHIAZIDE SODIUM, which is a drug marketed by Am Regent, Fresenius Kabi Usa, Rk Pharma, Sagent Pharms Inc, and Sun Pharm, and is included in five NDAs. It is available from four 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. Four 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. Four suppliers are listed for this compound. Additional details are available on the chlorothiazide sodium profile page.
Summary for 091546
| Tradename: | CHLOROTHIAZIDE SODIUM |
| Applicant: | Sun Pharm |
| Ingredient: | chlorothiazide sodium |
| Patents: | 0 |
Pharmacology for NDA: 091546
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 091546
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHLOROTHIAZIDE SODIUM | chlorothiazide sodium | INJECTABLE;INJECTION | 091546 | ANDA | Sun Pharmaceutical Industries, Inc. | 47335-330 | 47335-330-40 | 1 VIAL, SINGLE-DOSE in 1 CARTON (47335-330-40) / 18 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Jul 26, 2011 | TE: | AP | RLD: | No | ||||
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