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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 018596


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NDA 018596 describes INTAL, which is a drug marketed by King Pharms Llc and Sanofi Aventis Us and is included in three NDAs. Additional details are available on the INTAL profile page.

The generic ingredient in INTAL is cromolyn sodium. There are ten drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the cromolyn sodium profile page.
Summary for 018596
Tradename:INTAL
Applicant:King Pharms Llc
Ingredient:cromolyn sodium
Patents:0
Medical Subject Heading (MeSH) Categories for 018596

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INHALATIONStrength10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:May 28, 1982TE:RLD:Yes

Expired US Patents for NDA 018596

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
King Pharms Llc INTAL cromolyn sodium SOLUTION;INHALATION 018596-001 May 28, 1982 ⤷  Sign Up ⤷  Sign Up
King Pharms Llc INTAL cromolyn sodium SOLUTION;INHALATION 018596-001 May 28, 1982 ⤷  Sign Up ⤷  Sign Up
King Pharms Llc INTAL cromolyn sodium SOLUTION;INHALATION 018596-001 May 28, 1982 ⤷  Sign Up ⤷  Sign Up
King Pharms Llc INTAL cromolyn sodium SOLUTION;INHALATION 018596-001 May 28, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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