Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075346
Company: WOCKHARDT BIO AG

Products on ANDA 075346

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CROMOLYN SODIUM	CROMOLYN SODIUM	10MG/ML	SOLUTION;INHALATION	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075346

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/25/1999	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75346ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/15/2001	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 075346

CROMOLYN SODIUM

SOLUTION;INHALATION; 10MG/ML
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CROMOLYN SODIUM	CROMOLYN SODIUM	10MG/ML	SOLUTION;INHALATION	Prescription	No	AN	209453	AILEX PHARMS LLC
CROMOLYN SODIUM	CROMOLYN SODIUM	10MG/ML	SOLUTION;INHALATION	Prescription	No	AN	213658	MICRO LABS
CROMOLYN SODIUM	CROMOLYN SODIUM	10MG/ML	SOLUTION;INHALATION	Prescription	No	AN	075271	TEVA PHARMS
CROMOLYN SODIUM	CROMOLYN SODIUM	10MG/ML	SOLUTION;INHALATION	Prescription	No	AN	075437	VIRTUS
CROMOLYN SODIUM	CROMOLYN SODIUM	10MG/ML	SOLUTION;INHALATION	Prescription	No	AN	075346	WOCKHARDT BIO AG