Details for New Drug Application (NDA): 202745
✉ Email this page to a colleague
NDA 202745 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 202745
| Tradename: | CROMOLYN SODIUM |
| Applicant: | Micro Labs Ltd India |
| Ingredient: | cromolyn sodium |
| Patents: | 0 |
Pharmacology for NDA: 202745
| Physiological Effect | Decreased 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 / 8 AMPULE in 1 TRAY / 5 mL in 1 AMPULE (42571-132-21) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CONCENTRATE;ORAL | Strength | 100MG/5ML | ||||
| Approval Date: | Apr 4, 2013 | TE: | AA | RLD: | No | ||||
Complete Access Available with Subscription
