Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020479
Company: MYLAN SPECIALITY LP

Products on NDA 020479

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GASTROCROM	CROMOLYN SODIUM	100MG/5ML	CONCENTRATE;ORAL	Prescription	AA	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020479

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/29/1996	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/13/2003	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20479slr005ltr.pdf
12/16/1999	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
02/08/2000	SUPPL-2	Labeling		Label is not available on this site.
03/10/1999	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for NDA 020479

GASTROCROM

CONCENTRATE;ORAL; 100MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CROMOLYN SODIUM	CROMOLYN SODIUM	100MG/5ML	CONCENTRATE;ORAL	Prescription	No	AA	209264	AILEX PHARMS LLC
CROMOLYN SODIUM	CROMOLYN SODIUM	100MG/5ML	CONCENTRATE;ORAL	Prescription	No	AA	202745	MICRO LABS LTD INDIA
CROMOLYN SODIUM	CROMOLYN SODIUM	100MG/5ML	CONCENTRATE;ORAL	Prescription	No	AA	202583	RISING
GASTROCROM	CROMOLYN SODIUM	100MG/5ML	CONCENTRATE;ORAL	Prescription	Yes	AA	020479	MYLAN SPECIALITY LP