Details for New Drug Application (NDA): 208127
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NDA 208127 describes TRIMIPRAMINE MALEATE, which is a drug marketed by Breckenridge, Elite Labs Inc, and Usl Pharma, and is included in five NDAs. It is available from three suppliers. Additional details are available on the TRIMIPRAMINE MALEATE profile page.
The generic ingredient in TRIMIPRAMINE MALEATE is trimipramine maleate. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the trimipramine maleate profile page.
The generic ingredient in TRIMIPRAMINE MALEATE is trimipramine maleate. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the trimipramine maleate profile page.
Summary for 208127
| Tradename: | TRIMIPRAMINE MALEATE |
| Applicant: | Breckenridge |
| Ingredient: | trimipramine maleate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 208127
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIMIPRAMINE MALEATE | trimipramine maleate | CAPSULE;ORAL | 208127 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-944 | 51991-944-01 | 100 CAPSULE in 1 BOTTLE (51991-944-01) |
| TRIMIPRAMINE MALEATE | trimipramine maleate | CAPSULE;ORAL | 208127 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-944 | 51991-944-33 | 30 CAPSULE in 1 BOTTLE (51991-944-33) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Apr 15, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Apr 15, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Apr 15, 2016 | TE: | AB | RLD: | No | ||||
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