← FDA DRUG APPROVALS

FDA ANDA · ANDA075346

CROMOLYN SODIUM

Sponsor: WOCKHARDT BIO AG

APPLICATION
ANDA075346
TYPE
ANDA
ORIGINAL APPROVAL
1999-10-25
LATEST ACTION
2001-10-15
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

CROMOLYN SODIUMPrescription
CROMOLYN SODIUM 10MG/ML · SOLUTION · INHALATION

Approval history

2001-10-15Manufacturing (CMC) · Supplement 1AP
1999-10-25OriginalLetterAP
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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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