Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075702
Company: BAUSCH AND LOMB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CROMOLYN SODIUM CROMOLYN SODIUM 5.2MG/SPRAY SPRAY, METERED;NASAL Over-the-counter None No 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
07/03/2001 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-702_Cromolyn%20Sodium_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-702_Cromolyn%20Sodium_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-702_Cromolyn.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/03/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-702_Cromolyn%20Sodium_prntlbl.pdf

CROMOLYN SODIUM

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SPRAY, METERED;NASAL; 5.2MG/SPRAY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CROMOLYN SODIUM CROMOLYN SODIUM 5.2MG/SPRAY SPRAY, METERED;NASAL Over-the-counter No 075702 BAUSCH AND LOMB
CROMOLYN SODIUM CROMOLYN SODIUM 5.2MG/SPRAY SPRAY, METERED;NASAL Over-the-counter No 075427 PERRIGO

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