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Generated: December 13, 2018

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Details for New Drug Application (NDA): 202745

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NDA 202745 describes CROMOLYN SODIUM, which is a drug marketed by Ailex Pharms Llc, Genera Pharms, Micro Labs Ltd India, Rising Pharms, Akorn, Apotex Inc, Sandoz Inc, Actavis Mid Atlantic, Bausch And Lomb, Fera Pharms Llc, Mylan Speciality Lp, Roxane, Teva Pharms, Watson Labs, Wockhardt Bio Ag, Hh And P, and Perrigo, and is included in twenty-one NDAs. It is available from fourteen 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 202745
Tradename:CROMOLYN SODIUM
Applicant:Micro Labs Ltd India
Ingredient:cromolyn sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202745
Physiological EffectDecreased Histamine Release
Medical Subject Heading (MeSH) Categories for 202745
Suppliers and Packaging for NDA: 202745
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CROMOLYN SODIUM cromolyn sodium CONCENTRATE;ORAL 202745 ANDA Micro Labs Limited 42571-132 42571-132-52 96 CARTON in 1 CARTON (42571-132-52) > 1 TRAY in 1 CARTON (42571-132-51) > 8 AMPULE in 1 TRAY > 5 mL in 1 AMPULE (42571-132-21)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrength100MG/5ML
Approval Date:Apr 4, 2013TE:AARLD:No

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