Details for New Drug Application (NDA): 020479
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The generic ingredient in GASTROCROM 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 020479
Tradename: | GASTROCROM |
Applicant: | Mylan Speciality Lp |
Ingredient: | cromolyn sodium |
Patents: | 0 |
Pharmacology for NDA: 020479
Physiological Effect | Decreased Histamine Release |
Medical Subject Heading (MeSH) Categories for 020479
Suppliers and Packaging for NDA: 020479
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GASTROCROM | cromolyn sodium | CONCENTRATE;ORAL | 020479 | NDA | Meda Pharmaceuticals Inc. | 0037-0678 | 0037-0678-96 | 12 POUCH in 1 CARTON (0037-0678-96) / 8 AMPULE in 1 POUCH (0037-0678-08) / 5 mL in 1 AMPULE |
GASTROCROM | cromolyn sodium | CONCENTRATE;ORAL | 020479 | NDA AUTHORIZED GENERIC | Wallace Pharmaceuticals Inc. | 51525-0470 | 51525-0470-9 | 12 POUCH in 1 CARTON (51525-0470-9) / 8 AMPULE in 1 POUCH (51525-0470-8) / 5 mL in 1 AMPULE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CONCENTRATE;ORAL | Strength | 100MG/5ML | ||||
Approval Date: | Feb 29, 1996 | TE: | AA | RLD: | Yes |
Expired US Patents for NDA 020479
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Mylan Speciality Lp | GASTROCROM | cromolyn sodium | CONCENTRATE;ORAL | 020479-001 | Feb 29, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Mylan Speciality Lp | GASTROCROM | cromolyn sodium | CONCENTRATE;ORAL | 020479-001 | Feb 29, 1996 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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