Details for New Drug Application (NDA): 213412
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NDA 213412 describes CHLORTHALIDONE, which is a drug marketed by Abbott, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Ani Pharms, Appco, Ascot, Barr Labs Inc, Chartwell Rx, Cosette, Dava Pharms Inc, Inventia, Ivax Pharms, Kv Pharm, Mankind Pharma, Mutual Pharm, Mylan, Novast Labs, Pioneer Pharms, Purepac Pharm, Sandoz, Sun Pharm Industries, Sunny, Superpharm, Tagi, Umedica, Unichem, Usl Pharma, Vangard, Warner Chilcott, Watson Labs, and Zydus Pharms, and is included in fifty-eight 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 213412
| Tradename: | CHLORTHALIDONE |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | chlorthalidone |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213412
| Physiological Effect | Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 213412
Suppliers and Packaging for NDA: 213412
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHLORTHALIDONE | chlorthalidone | TABLET;ORAL | 213412 | ANDA | A-S Medication Solutions | 50090-5183 | 50090-5183-1 | 30 TABLET in 1 BOTTLE (50090-5183-1) |
| CHLORTHALIDONE | chlorthalidone | TABLET;ORAL | 213412 | ANDA | A-S Medication Solutions | 50090-6126 | 50090-6126-1 | 30 TABLET in 1 BOTTLE (50090-6126-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Feb 11, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Feb 11, 2020 | TE: | AB | RLD: | No | ||||
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