Details for New Drug Application (NDA): 212172
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NDA 212172 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 212172
| Tradename: | METHENAMINE HIPPURATE |
| Applicant: | Micro Labs |
| Ingredient: | methenamine hippurate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 212172
Suppliers and Packaging for NDA: 212172
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHENAMINE HIPPURATE | methenamine hippurate | TABLET;ORAL | 212172 | ANDA | Micro Labs Limited | 42571-332 | 42571-332-01 | 100 TABLET in 1 BOTTLE (42571-332-01) |
| METHENAMINE HIPPURATE | methenamine hippurate | TABLET;ORAL | 212172 | ANDA | Micro Labs Limited | 42571-332 | 42571-332-23 | 80 TABLET in 1 CARTON (42571-332-23) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1GM | ||||
| Approval Date: | Aug 1, 2019 | TE: | AB | RLD: | No | ||||
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