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FDA Product

ENALAPRIL MALEATE

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

Basic Information

ENALAPRIL MALEATE

64679-923

Regulatory Information

64679-923

ANDA075483

C73584

December 7, 2021

USA

ENALAPRIL MALEATE TABLETS, USP

HUMAN PRESCRIPTION DRUG LABEL

7

Company Information

Wockhardt USA LLC.

170508365

Active Ingredients

ENALAPRIL MALEATE

Quantity: 2.5 mg in 1 1

Code: 9O25354EPJ

Class Code: ACTIB

Inactive Ingredients

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

Active Moieties

ENALAPRILAT ANHYDROUS

Code: Q508Q118JM

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