Application 208253

Type: NDA
Sponsor: ALMIRALL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACTICLATE CAP	DOXYCYCLINE HYCLATE	CAPSULE;ORAL	EQ 75MG BASE	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16110-601	Acticlate	doxycycline hyclate	Aqua Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81859	SUPPL	2025-04-08
81803	SUPPL	2025-04-02
62050	SUPPL	2020-03-05
62045	SUPPL	2020-03-05
61496	SUPPL	2020-01-02
61465	SUPPL	2019-12-27
50520	SUPPL	2017-11-29
50417	SUPPL	2017-11-15
46041	ORIG	2016-10-26
46040	ORIG	2016-10-26
32901	ORIG	2016-04-27
19988	ORIG	2016-04-27