MedPath

Gastrocrom

(cromolyn sodium, USP)

Approved
Approval ID

00623958-a8fe-47d1-a0d2-0aa4e2f7966e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 10, 2018

Manufacturers
FDA

Meda Pharmaceuticals

DUNS: 051229602

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

cromolyn sodium

PRODUCT DETAILS

NDC Product Code0037-0678
Application NumberNDA020479
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 10, 2018
Generic Namecromolyn sodium

INGREDIENTS (2)

CROMOLYN SODIUMActive
Quantity: 20 mg in 1 mL
Code: Q2WXR1I0PK
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Gastrocrom - FDA Drug Approval Details