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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208253-001	ACTICLATE CAP	DOXYCYCLINE HYCLATE	EQ 75MG BASE	CAPSULE / ORAL		RLD	2016-04-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208253-001	ACTICLATE CAP	EQ 75MG BASE	CAPSULE / ORAL	RLD	2016-04-26	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Chartwell RX, LLC	fad03768-f1d2-459f-965e-0ec29f189f1f	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208253 application number: NDA208253
Acticlate CAP	DOXYCYCLINE HYCLATE	Aqua Pharmaceuticals	5e96d473-63dd-4446-88cf-eef2cd3339f0	2017-11-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208253 application number: NDA208253 ndc (product): 16110-601

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

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