Details for New Drug Application (NDA): 017386
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NDA 017386 describes ZAROXOLYN, which is a drug marketed by I3 Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the ZAROXOLYN profile page.
The generic ingredient in ZAROXOLYN is metolazone. There are ten drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the metolazone profile page.
The generic ingredient in ZAROXOLYN is metolazone. There are ten drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the metolazone profile page.
Summary for 017386
| Tradename: | ZAROXOLYN |
| Applicant: | I3 Pharms |
| Ingredient: | metolazone |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 017386
Suppliers and Packaging for NDA: 017386
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZAROXOLYN | metolazone | TABLET;ORAL | 017386 | NDA AUTHORIZED GENERIC | Aphena Pharma Solutions - Tennessee, LLC | 43353-999 | 43353-999-09 | 9000 TABLET in 1 BOTTLE, PLASTIC (43353-999-09) |
| ZAROXOLYN | metolazone | TABLET;ORAL | 017386 | NDA AUTHORIZED GENERIC | Aphena Pharma Solutions - Tennessee, LLC | 71610-142 | 71610-142-09 | 9000 TABLET in 1 BOTTLE, PLASTIC (71610-142-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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