Application 090134

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	TABLET, DELAYED RELEASE;ORAL	EQ 75MG BASE	No	No
002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	TABLET, DELAYED RELEASE;ORAL	EQ 100MG BASE	No	No
003	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	TABLET, DELAYED RELEASE;ORAL	EQ 50MG BASE	No	No
004	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	TABLET, DELAYED RELEASE;ORAL	EQ 200MG BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090134-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14
A090134-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14
A090134-003	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22
A090134-004	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A090134-001	AB
A090134-002	AB
A090134-003	AB
A090134-004	AB

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 5 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A090134-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090134-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090134-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090134-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090134-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090134-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090134-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090134-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090134-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090134-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090134-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090134-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090134-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090134-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090134-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090134-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A090134-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090134-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090134-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090134-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090134-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090134-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090134-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090134-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090134-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090134-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090134-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090134-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090134-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090134-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090134-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090134-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090134-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090134-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090134-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090134-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090134-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090134-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090134-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090134-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090134-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090134-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090134-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090134-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090134-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090134-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090134-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090134-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090134-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090134-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090134-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090134-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090134-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090134-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090134-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090134-004	AB	1	`2680178bc6a6…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Actavis Pharma, Inc.	c2b08332-3256-4658-965a-ede3d973a388	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090134 application number: ANDA090134 ndc (product): 0591-4550 ndc (product): 0591-4575

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-4550	Doxycycline Hyclate	Doxycycline Hyclate	Actavis Pharma, Inc.	ANDA	Current
0591-4550	Doxycycline Hyclate	Doxycycline Hyclate	Actavis Pharma, Inc.	ANDA	Current
0591-4550	Doxycycline Hyclate	Doxycycline Hyclate	Actavis Pharma, Inc.	ANDA	Current
0591-4575	Doxycycline Hyclate	Doxycycline Hyclate	Actavis Pharma, Inc.	ANDA	Current
0591-4575	Doxycycline Hyclate	Doxycycline Hyclate	Actavis Pharma, Inc.	ANDA	Current
0591-4575	Doxycycline Hyclate	Doxycycline Hyclate	Actavis Pharma, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54007	SUPPL	2018-05-03