Details for New Drug Application (NDA): 089763
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The generic ingredient in THEOPHYLLINE is theophylline. There are thirty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the theophylline profile page.
Summary for 089763
Tradename: | THEOPHYLLINE |
Applicant: | Heritage Pharma Avet |
Ingredient: | theophylline |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 089763
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
THEOPHYLLINE | theophylline | TABLET, EXTENDED RELEASE;ORAL | 089763 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-741 | 23155-741-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-741-01) |
THEOPHYLLINE | theophylline | TABLET, EXTENDED RELEASE;ORAL | 089763 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-741 | 23155-741-05 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-741-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 300MG | ||||
Approval Date: | Apr 30, 1990 | TE: | AB | RLD: | No |
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