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PREDNISONE

Prednisone tablet

Approved
Approval ID

a651e06c-6295-4ed2-8d67-334645f05b30

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 22, 2011

Manufacturers
FDA

RedPharm Drug Inc.

DUNS: 008039641

Products 1

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

prednisone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67296-0600
Application NumberANDA040392
Product Classification
M
Marketing Category
C73584
G
Generic Name
prednisone
Product Specifications
Route of AdministrationORAL
Effective DateJune 22, 2011
FDA Product Classification

INGREDIENTS (6)

FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PREDNISONEActive
Quantity: 20 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB

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PREDNISONE - FDA Drug Approval Details