Details for New Drug Application (NDA): 209264
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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 209264
Tradename: | CROMOLYN SODIUM |
Applicant: | Ailex Pharms Llc |
Ingredient: | cromolyn sodium |
Patents: | 0 |
Pharmacology for NDA: 209264
Physiological Effect | Decreased Histamine Release |
Medical Subject Heading (MeSH) Categories for 209264
Suppliers and Packaging for NDA: 209264
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CROMOLYN SODIUM | cromolyn sodium | CONCENTRATE;ORAL | 209264 | ANDA | Bryant Ranch Prepack | 63629-2483 | 63629-2483-1 | 12 POUCH in 1 CARTON (63629-2483-1) / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
CROMOLYN SODIUM | cromolyn sodium | CONCENTRATE;ORAL | 209264 | ANDA | Bryant Ranch Prepack | 63629-2485 | 63629-2485-1 | 12 POUCH in 1 CARTON (63629-2485-1) / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CONCENTRATE;ORAL | Strength | 100MG/5ML | ||||
Approval Date: | Oct 16, 2017 | TE: | AA | RLD: | No |
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