Details for New Drug Application (NDA): 217422
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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 217422
Tradename: | THEOPHYLLINE |
Applicant: | Annora Pharma |
Ingredient: | theophylline |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 217422
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
THEOPHYLLINE | theophylline | TABLET, EXTENDED RELEASE;ORAL | 217422 | ANDA | Camber Pharmaceuticals, Inc. | 31722-077 | 31722-077-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-077-01) |
THEOPHYLLINE | theophylline | TABLET, EXTENDED RELEASE;ORAL | 217422 | ANDA | Camber Pharmaceuticals, Inc. | 31722-078 | 31722-078-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-078-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 300MG | ||||
Approval Date: | Sep 8, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 450MG | ||||
Approval Date: | Sep 8, 2023 | TE: | AB | RLD: | No |
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