Details for New Drug Application (NDA): 200181
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NDA 200181 describes PHENELZINE SULFATE, which is a drug marketed by Novel Labs Inc and is included in one NDA. It is available from one supplier. Additional details are available on the PHENELZINE SULFATE profile page.
The generic ingredient in PHENELZINE SULFATE is phenelzine sulfate. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the phenelzine sulfate profile page.
The generic ingredient in PHENELZINE SULFATE is phenelzine sulfate. There are four drug master file entries for this compound. Three 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 |
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 | Lupin Pharmaceuticals,Inc. | 43386-360 | 43386-360-21 | 60 TABLET in 1 BOTTLE (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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