Details for New Drug Application (NDA): 215560
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NDA 215560 describes ATENOLOL AND CHLORTHALIDONE, which is a drug marketed by Aiping Pharm Inc, Aurobindo Pharma Usa, Nostrum Labs, Novitium Pharma, Pliva, Sun Pharm Industries, Unichem, Watson Labs, and Zydus Pharms, and is included in nine NDAs. It is available from nine suppliers. Additional details are available on the ATENOLOL AND CHLORTHALIDONE profile page.
The generic ingredient in ATENOLOL AND CHLORTHALIDONE is atenolol; chlorthalidone. There are thirty-four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the atenolol; chlorthalidone profile page.
The generic ingredient in ATENOLOL AND CHLORTHALIDONE is atenolol; chlorthalidone. There are thirty-four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the atenolol; chlorthalidone profile page.
Summary for 215560
| Tradename: | ATENOLOL AND CHLORTHALIDONE |
| Applicant: | Novitium Pharma |
| Ingredient: | atenolol; chlorthalidone |
| Patents: | 0 |
Pharmacology for NDA: 215560
| Mechanism of Action | Adrenergic beta-Antagonists |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 215560
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATENOLOL AND CHLORTHALIDONE | atenolol; chlorthalidone | TABLET;ORAL | 215560 | ANDA | MARLEX PHARMACEUTICALS, INC | 10135-733 | 10135-733-01 | 100 TABLET in 1 BOTTLE (10135-733-01) |
| ATENOLOL AND CHLORTHALIDONE | atenolol; chlorthalidone | TABLET;ORAL | 215560 | ANDA | MARLEX PHARMACEUTICALS, INC | 10135-734 | 10135-734-01 | 100 TABLET in 1 BOTTLE (10135-734-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG;25MG | ||||
| Approval Date: | Oct 25, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG;25MG | ||||
| Approval Date: | Oct 25, 2021 | TE: | AB | RLD: | No | ||||
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