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Lorazepam

Lorazepam Tablets, USP

Approved
Approval ID

90d64ec4-e3af-4e78-bf7e-9d37699c98d2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 1, 2010

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 3

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

Lorazepam

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-239
Application NumberANDA071194
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2008
FDA Product Classification

INGREDIENTS (6)

lactoseInactive
Code: J2B2A4N98G
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LorazepamActive
Quantity: 1 mg in 1 1
Code: O26FZP769L
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT

Lorazepam

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-238
Application NumberANDA071193
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2008
FDA Product Classification

INGREDIENTS (6)

HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
LorazepamActive
Quantity: 0.5 mg in 1 1
Code: O26FZP769L
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT

Lorazepam

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-240
Application NumberANDA071195
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2008
FDA Product Classification

INGREDIENTS (6)

HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LorazepamActive
Quantity: 2 mg in 1 1
Code: O26FZP769L
Classification: ACTIB
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

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Lorazepam - FDA Drug Approval Details