Details for New Drug Application (NDA): 209453
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NDA 209453 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.
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 209453
| Tradename: | CROMOLYN SODIUM |
| Applicant: | Ailex Pharms Llc |
| Ingredient: | cromolyn sodium |
| Patents: | 0 |
Pharmacology for NDA: 209453
| Physiological Effect | Decreased Histamine Release |
Medical Subject Heading (MeSH) Categories for 209453
Suppliers and Packaging for NDA: 209453
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CROMOLYN SODIUM | cromolyn sodium | SOLUTION;INHALATION | 209453 | ANDA | Woodward Pharma Services LLC | 69784-205 | 69784-205-60 | 2 POUCH in 1 CARTON (69784-205-60) / 30 VIAL, SINGLE-DOSE in 1 POUCH (69784-205-30) / 2 mL in 1 VIAL, SINGLE-DOSE |
| CROMOLYN SODIUM | cromolyn sodium | SOLUTION;INHALATION | 209453 | ANDA | Ailex Pharmaceuticals, LLC | 70556-102 | 70556-102-60 | 2 POUCH in 1 CARTON (70556-102-60) / 30 VIAL, SINGLE-DOSE in 1 POUCH (70556-102-30) / 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: | Oct 16, 2017 | TE: | AN | RLD: | No | ||||
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