Details for New Drug Application (NDA): 206344
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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 206344
Tradename: | THEOPHYLLINE |
Applicant: | Pharm Assoc |
Ingredient: | theophylline |
Patents: | 0 |
Suppliers and Packaging for NDA: 206344
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
THEOPHYLLINE | theophylline | SOLUTION, ELIXIR;ORAL | 206344 | ANDA | PAI Holdings, LLC | 0121-0820 | 0121-0820-04 | 118 mL in 1 BOTTLE (0121-0820-04) |
THEOPHYLLINE | theophylline | SOLUTION, ELIXIR;ORAL | 206344 | ANDA | PAI Holdings, LLC | 0121-0820 | 0121-0820-16 | 473 mL in 1 BOTTLE (0121-0820-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION, ELIXIR;ORAL | Strength | 80MG/15ML | ||||
Approval Date: | Dec 16, 2016 | TE: | AA | RLD: | No |
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