Drugs@FDA: FDA Approved Drug Products

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

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

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