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Phenelzine Sulfate

PHENELZINE SULFATE TABLETS, USP Novel Laboratories, Inc. Rx Only

Approved
Approval ID

b7ec6ae7-3d76-42aa-9d8a-fc3e187769b5

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 30, 2014

Manufacturers
FDA

Novel Laboratories, Inc.

DUNS: 793518643

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Phenelzine Sulfate

PRODUCT DETAILS

NDC Product Code40032-360
Application NumberANDA200181
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 30, 2014
Generic NamePhenelzine Sulfate

INGREDIENTS (11)

PHENELZINE SULFATEActive
Quantity: 15 mg in 1 1
Code: 2681D7P965
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

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Phenelzine Sulfate - FDA Drug Approval Details