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FDA Drug information

Theophylline

Read time: 1 mins
Marketing start date: 26 Jan 2025
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Summary of product characteristics


Effective Time

20240522

Version

1

Spl Product Data Elements

Theophylline Theophylline THEOPHYLLINE ANHYDROUS THEOPHYLLINE ANHYDROUS HYPROMELLOSE 2208 (100 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE off white biconvex 7;28 Theophylline Theophylline THEOPHYLLINE ANHYDROUS THEOPHYLLINE ANHYDROUS HYPROMELLOSE 2208 (100 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE off white biconvex 7;29

Application Number

ANDA218063

Brand Name

Theophylline

Generic Name

Theophylline

Product Ndc

70771-1782

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Theophylline extended-release tablets, 300 mg 100 Tablets NDC 70771-1782-1 Rx only Theophylline extended-release tablets, 450 mg 100 Tablets NDC 70771-1783-1 Rx only Theophylline Extended-Release Tablets 300mg Theophylline Extended-Release Tablets 450 mg

Drug section

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