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ACYCLOVIR

Acyclovir tablets

Approved
Approval ID

ffa99978-6b66-49ab-9bd2-8ef6f6846cd7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 30, 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.

acyclovir

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67296-0375
Application NumberANDA074596
Product Classification
M
Marketing Category
C73584
G
Generic Name
acyclovir
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2011
FDA Product Classification

INGREDIENTS (6)

AcyclovirActive
Quantity: 400 mg in 1 1
Code: X4HES1O11F
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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ACYCLOVIR - FDA Drug Approval Details