Details for New Drug Application (NDA): 210068
NDA 210068 describes METHENAMINE HIPPURATE, which is a drug marketed by Aurobindo Pharma Ltd, Impax Labs Inc, Ingenus Pharms Llc, Jubilant Cadista, Micro Labs, and Zydus Lifesciences, and is included in six NDAs. It is available from ten suppliers. Additional details are available on the METHENAMINE HIPPURATE profile page.
The generic ingredient in METHENAMINE HIPPURATE is methenamine hippurate. There is one drug master file entry for this compound. Twelve 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 is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the methenamine hippurate profile page.
Summary for 210068
| Tradename: | METHENAMINE HIPPURATE |
| Applicant: | Ingenus Pharms Llc |
| 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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