DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 200181
The generic ingredient in PHENELZINE SULFATE is phenelzine sulfate. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the phenelzine sulfate profile page.
Summary for 200181
Tradename: | PHENELZINE SULFATE |
Applicant: | Novel Labs Inc |
Ingredient: | phenelzine sulfate |
Patents: | 0 |
Therapeutic Class: | Antidepressants |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 200181
Mechanism of Action | Monoamine Oxidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 200181
Suppliers and Packaging for NDA: 200181
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PHENELZINE SULFATE | phenelzine sulfate | TABLET;ORAL | 200181 | ANDA | Novel Laboratories, Inc. | 40032-360 | N | 40032-360-21 |
PHENELZINE SULFATE | phenelzine sulfate | TABLET;ORAL | 200181 | ANDA | Lupin Pharmaceuticals,Inc. | 43386-360 | N | 43386-360-21 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 15MG BASE | ||||
Approval Date: | Dec 8, 2010 | TE: | AB | RLD: | No |
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