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Loxapine

Loxapine Capsules USP Revised: September 2010 Rx only 174374-2

Approved
Approval ID

337bb945-64b9-4da5-8c10-1aead291c184

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 4, 2011

Manufacturers
FDA

Carilion Materials Management

DUNS: 079239644

Products 1

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

Loxapine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68151-2875
Application NumberANDA072204
Product Classification
M
Marketing Category
C73584
G
Generic Name
Loxapine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2011
FDA Product Classification

INGREDIENTS (14)

ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
LOXAPINE SUCCINATEActive
Quantity: 5 mg in 1 1
Code: X59SG0MRYU
Classification: ACTIM
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM PROPIONATEInactive
Code: DK6Y9P42IN
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT

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Loxapine - FDA Drug Approval Details