Details for New Drug Application (NDA): 017681
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NDA 017681 describes HIPREX, which is a drug marketed by Esjay Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the HIPREX profile page.
The generic ingredient in HIPREX is methenamine hippurate. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the methenamine hippurate profile page.
The generic ingredient in HIPREX is methenamine hippurate. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the methenamine hippurate profile page.
Summary for 017681
| Tradename: | HIPREX |
| Applicant: | Esjay Pharma |
| Ingredient: | methenamine hippurate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 017681
Suppliers and Packaging for NDA: 017681
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HIPREX | methenamine hippurate | TABLET;ORAL | 017681 | NDA | Validus Pharmaceuticals LLC | 30698-477 | 30698-477-01 | 100 TABLET in 1 BOTTLE (30698-477-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1GM | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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