Neothylline

NDA 9088, held by Teva. Dyphylline.

As of Nov 13, 2026, NDA 9088 (Neothylline), held by Teva, was first approved by FDA on Sep 28, 1953, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 28, 1953
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Sep 28, 1953	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Neothylline250MG/ML · injectable;injection	Dyphylline	Discontinued

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 12, 1998	Supplement 4Labeling	Approved	None posted
May 12, 1998	Supplement 6Labeling	Approved	None posted
Sep 28, 1953	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 9088
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters