← FDA DRUG APPROVALS

FDA NDA · NDA020479

GASTROCROM

cromolyn sodium

Sponsor: VIATRIS SPECIALTY

APPLICATION
NDA020479
TYPE
NDA
ORIGINAL APPROVAL
1996-02-29
LATEST ACTION
2003-02-13
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Prescription

Products

GASTROCROM · ReferencePrescription
CROMOLYN SODIUM 100MG/5ML · CONCENTRATE · ORAL

Approval history

2003-02-13Labeling · Supplement 5 · standard — Letter ↗AP
2000-02-08Labeling · Supplement 2 · standardAP
1999-12-16Manufacturing (CMC) · Supplement 3 · standardAP
1999-03-10Manufacturing (CMC) · Supplement 1 · standardAP
1996-02-29Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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