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Details for New Drug Application (NDA): 019188

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NDA 019188 describes GASTROCROM, which is a drug marketed by Meda Pharms and Ucb Inc and is included in two NDAs. It is available from four 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. Sixteen suppliers are listed for this compound. Additional details are available on the cromolyn sodium profile page.

Summary for NDA: 019188

Tradename:
GASTROCROM
Applicant:
Ucb Inc
Ingredient:
cromolyn sodium
Patents:0
Therapeutic Class:Ophthalmic Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength100MG
Approval Date:Dec 22, 1989TE:RLD:No

Expired Orange Book Patents for NDA: 019188

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc
GASTROCROM
cromolyn sodium
CAPSULE;ORAL019188-001Dec 22, 19894,395,421► subscribe
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