Details for New Drug Application (NDA): 075580
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NDA 075580 describes DOXAZOSIN MESYLATE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Ani Pharms, Apotex, Appco, Aurobindo Pharma Usa, Chartwell Rx, Genpharm, Heritage Pharma, Ivax Sub Teva Pharms, Nesher Pharms, Pliva, Rising, Strides Pharma Intl, Teva, Unichem, Watson Labs Inc, and Zydus Pharms, and is included in nineteen NDAs. It is available from twenty-nine suppliers. Additional details are available on the DOXAZOSIN MESYLATE profile page.
The generic ingredient in DOXAZOSIN MESYLATE is doxazosin mesylate. There are fourteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the doxazosin mesylate profile page.
The generic ingredient in DOXAZOSIN MESYLATE is doxazosin mesylate. There are fourteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the doxazosin mesylate profile page.
Summary for 075580
| Tradename: | DOXAZOSIN MESYLATE |
| Applicant: | Apotex |
| Ingredient: | doxazosin mesylate |
| Patents: | 0 |
Pharmacology for NDA: 075580
| Mechanism of Action | Adrenergic alpha-Antagonists |
Medical Subject Heading (MeSH) Categories for 075580
Suppliers and Packaging for NDA: 075580
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXAZOSIN MESYLATE | doxazosin mesylate | TABLET;ORAL | 075580 | ANDA | Major Pharmaceuticals | 0904-5522 | 0904-5522-61 | 100 BLISTER PACK in 1 CARTON (0904-5522-61) / 1 TABLET in 1 BLISTER PACK |
| DOXAZOSIN MESYLATE | doxazosin mesylate | TABLET;ORAL | 075580 | ANDA | Major Pharmaceuticals | 0904-5523 | 0904-5523-61 | 100 BLISTER PACK in 1 CARTON (0904-5523-61) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Oct 18, 2000 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | Oct 18, 2000 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE | ||||
| Approval Date: | Oct 18, 2000 | TE: | AB | RLD: | No | ||||
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