Details for New Drug Application (NDA): 090355
✉ Email this page to a colleague
The generic ingredient in THEOPHYLLINE is theophylline. There are thirty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the theophylline profile page.
Summary for 090355
Tradename: | THEOPHYLLINE |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | theophylline |
Patents: | 0 |
Suppliers and Packaging for NDA: 090355
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
THEOPHYLLINE | theophylline | TABLET, EXTENDED RELEASE;ORAL | 090355 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-356 | 68462-356-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-356-01) |
THEOPHYLLINE | theophylline | TABLET, EXTENDED RELEASE;ORAL | 090355 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-356 | 68462-356-05 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-356-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 400MG | ||||
Approval Date: | Jul 13, 2010 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 600MG | ||||
Approval Date: | Jul 13, 2010 | TE: | AB | RLD: | No |
Complete Access Available with Subscription