Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075282
Company: SANDOZ

Products on ANDA 075282

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CROMOLYN SODIUM	CROMOLYN SODIUM	4%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075282

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/16/1999	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75282ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2002	SUPPL-5	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/01/2002	SUPPL-4	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/28/2002	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/07/2000	SUPPL-2	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/07/1999	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 075282

CROMOLYN SODIUM

SOLUTION/DROPS;OPHTHALMIC; 4%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CROMOLYN SODIUM	CROMOLYN SODIUM	4%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	075282	SANDOZ