FDA Product

Roflumilast

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Roflumilast

FDA Product Code

70771-1674

Regulatory Information

NDC Product Code

70771-1674

Application Number

ANDA208303

Marketing Category

C73584

Effective Date

September 27, 2023

Territorial Authority

USA

FDA Title

Roflumilast Tablets, for oral use

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

3

Company Information

ManufacturerZydus Lifesciences Limited

DUNS Number

918596198

Active Ingredients

Quantity: 500 ug in 1 1

Code: 0P6C6ZOP5U

Class Code: ACTIB

Inactive Ingredients

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED

Code: 2165RE0K14

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

POLOXAMER 407

Code: TUF2IVW3M2

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

Active Moieties

ROFLUMILAST

Code: 0P6C6ZOP5U

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