Details for New Drug Application (NDA): 210068
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NDA 210068 describes METHENAMINE HIPPURATE, which is a drug marketed by Aurobindo Pharma Ltd, Impax Labs Inc, Jubilant Cadista, Micro Labs, and Novast Labs, and is included in five NDAs. It is available from seven suppliers. Additional details are available on the METHENAMINE HIPPURATE profile page.
The generic ingredient in METHENAMINE HIPPURATE 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 METHENAMINE HIPPURATE 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 210068
| Tradename: | METHENAMINE HIPPURATE |
| Applicant: | Novast Labs |
| Ingredient: | methenamine hippurate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 210068
Suppliers and Packaging for NDA: 210068
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHENAMINE HIPPURATE | methenamine hippurate | TABLET;ORAL | 210068 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-142 | 50742-142-01 | 100 TABLET in 1 BOTTLE (50742-142-01) |
| METHENAMINE HIPPURATE | methenamine hippurate | TABLET;ORAL | 210068 | ANDA | Golden State Medical Supply, Inc. | 51407-880 | 51407-880-01 | 100 TABLET in 1 BOTTLE (51407-880-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1GM | ||||
| Approval Date: | Nov 27, 2020 | TE: | AB | RLD: | No | ||||
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