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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075271
Company: TEVA PHARMS

Products on ANDA 075271

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075271

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/18/2000	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-271_Cromolyn%20Sodium_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75271ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-271_Cromolyn.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/03/2008	SUPPL-7	Labeling		Label is not available on this site.
08/15/2001	SUPPL-2	Labeling		Label is not available on this site.
08/15/2001	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for ANDA 075271

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/18/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-271_Cromolyn%20Sodium_prntlbl.pdf

Therapeutic Equivalents for ANDA 075271

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

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