DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 075702
NDA 075702 describes CROMOLYN SODIUM, which is a drug marketed by Ailex Pharms Llc, Genera Pharms, Micro Labs Ltd India, Rising Pharms Inc, 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 twelve 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 075702
| Tradename: | CROMOLYN SODIUM |
| Applicant: | Bausch And Lomb |
| Ingredient: | cromolyn sodium |
| Patents: | 0 |
| Therapeutic Class: | Ophthalmic Agents Respiratory Tract Agents |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 075702
Suppliers and Packaging for NDA: 075702
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CROMOLYN SODIUM | cromolyn sodium | SPRAY, METERED;NASAL | 075702 | ANDA | Major Pharmaceuticals | 0904-5532 | N | 0904-5532-67 |
| CROMOLYN SODIUM | cromolyn sodium | SPRAY, METERED;NASAL | 075702 | ANDA | Cardinal Health | 37205-223 | N | 37205-223-61 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SPRAY, METERED;NASAL | Strength | 5.2MG/SPRAY | ||||
| Approval Date: | Jul 3, 2001 | TE: | RLD: | No | |||||
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