Details for New Drug Application (NDA): 206856
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NDA 206856 describes TRANYLCYPROMINE SULFATE, which is a drug marketed by Crossmedika Sa, Novitium Pharma, and Strides Pharma, and is included in three NDAs. It is available from four suppliers. Additional details are available on the TRANYLCYPROMINE SULFATE profile page.
The generic ingredient in TRANYLCYPROMINE SULFATE is tranylcypromine sulfate. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the tranylcypromine sulfate profile page.
The generic ingredient in TRANYLCYPROMINE SULFATE is tranylcypromine sulfate. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the tranylcypromine sulfate profile page.
Summary for 206856
| Tradename: | TRANYLCYPROMINE SULFATE |
| Applicant: | Novitium Pharma |
| Ingredient: | tranylcypromine sulfate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206856
| Mechanism of Action | Monoamine Oxidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 206856
Suppliers and Packaging for NDA: 206856
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRANYLCYPROMINE SULFATE | tranylcypromine sulfate | TABLET;ORAL | 206856 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-739 | 10135-739-01 | 100 TABLET in 1 BOTTLE (10135-739-01) |
| TRANYLCYPROMINE SULFATE | tranylcypromine sulfate | TABLET;ORAL | 206856 | ANDA | Novitium Pharma LLC | 70954-538 | 70954-538-10 | 100 TABLET in 1 BOTTLE (70954-538-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Apr 17, 2018 | TE: | AB | RLD: | No | ||||
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