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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 020479


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NDA 020479 describes GASTROCROM, which is a drug marketed by Ucb Inc and Mylan Speciality Lp and is included in two NDAs. It is available from two suppliers. Additional details are available on the GASTROCROM profile page.

The generic ingredient in GASTROCROM 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 020479
Tradename:GASTROCROM
Applicant:Mylan Speciality Lp
Ingredient:cromolyn sodium
Patents:0
Pharmacology for NDA: 020479
Physiological EffectDecreased Histamine Release
Medical Subject Heading (MeSH) Categories for 020479
Suppliers and Packaging for NDA: 020479
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GASTROCROM cromolyn sodium CONCENTRATE;ORAL 020479 NDA Meda Pharmaceuticals Inc. 0037-0678 0037-0678-96 12 POUCH in 1 CARTON (0037-0678-96) / 8 AMPULE in 1 POUCH (0037-0678-08) / 5 mL in 1 AMPULE
GASTROCROM cromolyn sodium CONCENTRATE;ORAL 020479 NDA AUTHORIZED GENERIC Wallace Pharmaceuticals Inc. 51525-0470 51525-0470-9 12 POUCH in 1 CARTON (51525-0470-9) / 8 AMPULE in 1 POUCH (51525-0470-8) / 5 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrength100MG/5ML
Approval Date:Feb 29, 1996TE:AARLD:Yes

Expired US Patents for NDA 020479

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp GASTROCROM cromolyn sodium CONCENTRATE;ORAL 020479-001 Feb 29, 1996 ⤷  Sign Up ⤷  Sign Up
Mylan Speciality Lp GASTROCROM cromolyn sodium CONCENTRATE;ORAL 020479-001 Feb 29, 1996 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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