Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 202583
Company: RISING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CROMOLYN SODIUM CROMOLYN SODIUM 100MG/5ML CONCENTRATE;ORAL Prescription AA No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/27/2011 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202583s000ltr.pdf

CROMOLYN SODIUM

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English