Doryx

NDA 50582, held by Mayne Pharma. Doxycycline Hyclate.

As of Nov 13, 2026, NDA 50582 (Doryx), held by Mayne Pharma, was first approved by FDA on Jul 22, 1985, with 25 approved supplements and 0 published complete response letters.

First approved: Jul 22, 1985
Review: Standard
Supplements approved: 25
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 26 submissions below

Date	Submission	Status	Documents
Jul 22, 1985	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


DoryxEQ 100MG BASE · capsule, delayed release;oral	Doxycycline Hyclate	DiscontinuedReference drug
DoryxEQ 75MG BASE · capsule, delayed release;oral	Doxycycline Hyclate	DiscontinuedReference drug

All 26 submissions, including labeling and manufacturing supplements


Mar 31, 2025	Supplement 32Labeling · Standard review	Approved	Letter Label
Mar 2, 2020	Supplement 31Labeling · Standard review	Approved	Letter Label
Feb 7, 2018	Supplement 30Labeling · Standard review	Approved	Label Letter
Sep 2, 2015	Supplement 29Labeling · Standard review	Approved	Letter Label
Mar 21, 2011	Supplement 28Labeling · Standard review	Approved	Letter
Feb 7, 2008	Supplement 27Labeling · Standard review	Approved	Label Letter
May 6, 2005	Supplement 24Labeling · Standard review	Approved	Letter Label
Feb 13, 2004	Supplement 22Labeling · Standard review	Approved	Letter
Jun 5, 2003	Supplement 21Labeling · Standard review	Approved	Letter
Oct 25, 2002	Supplement 18Manufacturing · Standard review	Approved	None posted
Jun 18, 2002	Supplement 16Labeling · Standard review	Approved	Letter
May 22, 2002	Supplement 17Manufacturing · Standard review	Approved	None posted
Aug 13, 2001	Supplement 15Manufacturing · Standard review	Approved	None posted
May 4, 2001	Supplement 14Manufacturing · Standard review	Approved	None posted
Mar 15, 2001	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 1, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 29, 1993	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 26, 1991	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 26, 1991	Supplement 9Manufacturing · Standard review	Approved	None posted
May 30, 1986	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 2, 1985	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 17, 1985	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 17, 1985	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 17, 1985	Supplement 2Labeling	Approved	None posted
Sep 12, 1985	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 22, 1985	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50582
Drugs@FDA: Overview at FDA
Company: Mayne Pharma

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