Details for New Drug Application (NDA): 215587
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NDA 215587 describes CHLORTHALIDONE, which is a drug marketed by Abbott, Aiping Pharm Inc, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Ani Pharms, Appco, Ascot, Barr Labs Inc, Chartwell Rx, Cosette, Dava Pharms Inc, Inventia, Ipca Labs Ltd, Ivax Pharms, Kv Pharm, Mankind Pharma, Mutual Pharm, Mylan, Novast Labs, Pharmobedient, Pioneer Pharms, Purepac Pharm, Sandoz, Sun Pharm Industries, Sunny, Superpharm, Umedica, Unichem, Usl Pharma, Vangard, Warner Chilcott, Watson Labs, and Zydus Pharms, and is included in fifty-nine NDAs. It is available from thirty-four suppliers. Additional details are available on the CHLORTHALIDONE profile page.
The generic ingredient in CHLORTHALIDONE 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 CHLORTHALIDONE 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 215587
| Tradename: | CHLORTHALIDONE |
| Applicant: | Mankind Pharma |
| Ingredient: | chlorthalidone |
| Patents: | 0 |
Pharmacology for NDA: 215587
| Physiological Effect | Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 215587
Suppliers and Packaging for NDA: 215587
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHLORTHALIDONE | chlorthalidone | TABLET;ORAL | 215587 | ANDA | Bryant Ranch Prepack | 63629-4446 | 63629-4446-1 | 90 TABLET in 1 BOTTLE (63629-4446-1) |
| CHLORTHALIDONE | chlorthalidone | TABLET;ORAL | 215587 | ANDA | REMEDYREPACK INC. | 70518-3718 | 70518-3718-0 | 30 TABLET in 1 BLISTER PACK (70518-3718-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Aug 4, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Aug 4, 2022 | TE: | AB | RLD: | No | ||||
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