Details for New Drug Application (NDA): 216276
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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 216276
Tradename: | THEOPHYLLINE |
Applicant: | Amneal |
Ingredient: | theophylline |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 216276
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
THEOPHYLLINE | theophylline | TABLET, EXTENDED RELEASE;ORAL | 216276 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-2045 | 60219-2045-1 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2045-1) |
THEOPHYLLINE | theophylline | TABLET, EXTENDED RELEASE;ORAL | 216276 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-2045 | 60219-2045-3 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2045-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 300MG | ||||
Approval Date: | Mar 20, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 450MG | ||||
Approval Date: | Mar 20, 2023 | TE: | AB | RLD: | No |
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