Details for New Drug Application (NDA): 209013
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NDA 209013 describes DOXAZOSIN MESYLATE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Ani Pharms, Apotex, Aurobindo Pharma Usa, Chartwell Rx, Genpharm, Heritage Pharma, Ivax Sub Teva Pharms, Nesher Pharms, Pliva, Rising, Strides Pharma, Teva, Unichem, Upsher Smith Labs, 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 209013
| Tradename: | DOXAZOSIN MESYLATE |
| Applicant: | Upsher Smith Labs |
| Ingredient: | doxazosin mesylate |
| Patents: | 0 |
Pharmacology for NDA: 209013
| Mechanism of Action | Adrenergic alpha-Antagonists |
Medical Subject Heading (MeSH) Categories for 209013
Suppliers and Packaging for NDA: 209013
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXAZOSIN MESYLATE | doxazosin mesylate | TABLET;ORAL | 209013 | ANDA | Upsher-Smith laboratories, LLC | 0832-0356 | 0832-0356-11 | 100 TABLET in 1 BOTTLE (0832-0356-11) |
| DOXAZOSIN MESYLATE | doxazosin mesylate | TABLET;ORAL | 209013 | ANDA | Upsher-Smith laboratories, LLC | 0832-0357 | 0832-0357-11 | 100 TABLET in 1 BOTTLE (0832-0357-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Apr 17, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | Apr 17, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE | ||||
| Approval Date: | Apr 17, 2018 | TE: | AB | RLD: | No | ||||
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