Details for New Drug Application (NDA): 075437
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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 075437
Tradename: | CROMOLYN SODIUM |
Applicant: | Virtus |
Ingredient: | cromolyn sodium |
Patents: | 0 |
Pharmacology for NDA: 075437
Physiological Effect | Decreased Histamine Release |
Medical Subject Heading (MeSH) Categories for 075437
Suppliers and Packaging for NDA: 075437
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CROMOLYN SODIUM | cromolyn sodium | SOLUTION;INHALATION | 075437 | ANDA | VIRTUS PHARMACEUTICALS LLC | 69543-456 | 69543-456-60 | 5 POUCH in 1 CARTON (69543-456-60) / 12 VIAL, SINGLE-DOSE in 1 POUCH (69543-456-12) / 2 mL in 1 VIAL, SINGLE-DOSE |
CROMOLYN SODIUM | cromolyn sodium | SOLUTION;INHALATION | 075437 | ANDA | Bryant Ranch Prepack | 72162-2307 | 72162-2307-6 | 5 POUCH in 1 CARTON (72162-2307-6) / 12 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 10MG/ML | ||||
Approval Date: | Apr 21, 2000 | TE: | AN | RLD: | No |
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