Details for New Drug Application (NDA): 078512
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NDA 078512 describes ATENOLOL, which is a drug marketed by Able, Apothecon, Aurobindo Pharma, Chartwell Rx, Hlthcare, Ipca Labs Ltd, Mylan, Northstar Hlthcare, Nostrum Labs, Pliva, SCS, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Teva Pharms, Twi Pharms, Unichem, Unique, Watson Labs, Watson Labs Teva, Zydus Pharms Usa, Aurobindo Pharma Usa, Novitium Pharma, and Zydus Pharms, and is included in thirty-nine NDAs. It is available from thirty-three suppliers. Additional details are available on the ATENOLOL profile page.
The generic ingredient in ATENOLOL is atenolol; chlorthalidone. There are thirty-four drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the atenolol; chlorthalidone profile page.
The generic ingredient in ATENOLOL is atenolol; chlorthalidone. There are thirty-four drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the atenolol; chlorthalidone profile page.
Summary for 078512
| Tradename: | ATENOLOL |
| Applicant: | Aurobindo Pharma |
| Ingredient: | atenolol |
| Patents: | 0 |
Pharmacology for NDA: 078512
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 078512
Suppliers and Packaging for NDA: 078512
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATENOLOL | atenolol | TABLET;ORAL | 078512 | ANDA | Major Pharmaceuticals | 0904-7187 | 0904-7187-61 | 100 BLISTER PACK in 1 CARTON (0904-7187-61) / 1 TABLET in 1 BLISTER PACK |
| ATENOLOL | atenolol | TABLET;ORAL | 078512 | ANDA | QPharma Inc | 42708-162 | 42708-162-30 | 30 TABLET in 1 BOTTLE, PLASTIC (42708-162-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Oct 31, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Oct 31, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Oct 31, 2007 | TE: | AB | RLD: | No | ||||
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