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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 075282


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NDA 075282 describes CROMOLYN SODIUM, which is a drug marketed by Ailex Pharms Llc, Genera Pharms, Micro Labs Ltd India, Rising, Apotex Inc, Sandoz, Sciegen Pharms Inc, Actavis Mid Atlantic, Bausch, Eugia Pharma, Hikma, Micro Labs, Roxane, Teva Pharms, Virtus, Watson Labs, Wockhardt Bio Ag, Bausch And Lomb, Hh And P, and Perrigo, and is included in twenty-two NDAs. It is available from sixteen suppliers. Additional details are available on the CROMOLYN SODIUM profile page.

The generic ingredient in CROMOLYN SODIUM is cromolyn sodium. There are ten drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the cromolyn sodium profile page.
Summary for 075282
Tradename:CROMOLYN SODIUM
Applicant:Sandoz
Ingredient:cromolyn sodium
Patents:0
Pharmacology for NDA: 075282
Physiological EffectDecreased Histamine Release
Medical Subject Heading (MeSH) Categories for 075282
Suppliers and Packaging for NDA: 075282
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CROMOLYN SODIUM cromolyn sodium SOLUTION/DROPS;OPHTHALMIC 075282 ANDA A-S Medication Solutions 50090-1202 50090-1202-0 10 mL in 1 BOTTLE, PLASTIC (50090-1202-0)
CROMOLYN SODIUM cromolyn sodium SOLUTION/DROPS;OPHTHALMIC 075282 ANDA RPK Pharmaceuticals, Inc. 53002-0140 53002-0140-1 10 mL in 1 BOTTLE, PLASTIC (53002-0140-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength4%
Approval Date:Jun 16, 1999TE:RLD:No

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