Aminophylline

ANDA 85564, held by Watson Labs. Aminophylline.

As of Nov 15, 2026, ANDA 85564 (Aminophylline), held by Watson Labs, was not approved, with 7 approved supplements and 0 published complete response letters.

First approved: Not approved
Supplements approved: 7
Complete response letters: 0

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aminophylline200MG · tablet;oral	Aminophylline	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Nov 7, 1986	Supplement 21Manufacturing	Approved	None posted
Dec 4, 1984	Supplement 18Manufacturing	Approved	None posted
Dec 4, 1984	Supplement 19Manufacturing	Approved	None posted
Dec 4, 1984	Supplement 20Manufacturing	Approved	None posted
Feb 24, 1982	Supplement 5Manufacturing	Approved	None posted
Feb 24, 1982	Supplement 6Manufacturing	Approved	None posted
Feb 24, 1982	Supplement 11Manufacturing	Approved	None posted

Identifiers

Application: ANDA 85564
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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