Application 062421

Type: ANDA
Sponsor: ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	TABLET;ORAL	EQ 100MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A062421-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		1983-02-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062421-001	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 1 of 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062421-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1983-02-02	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062421-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062421-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062421-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062421-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062421-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062421-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062421-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062421-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062421-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062421-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062421-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062421-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062421-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062421-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062421-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062421-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062421-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062421-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062421-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062421-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062421-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062421-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062421-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062421-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062421-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062421-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062421-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062421-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062421-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062421-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062421-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062421-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062421-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062421-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062421-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062421-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062421-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062421-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062421-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062421-001	AB	1	`cb3db0bc1861…`

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	Actavis Pharma, Inc.	a569ba80-ffea-40b2-9fbe-a42810b1fccb	2025-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062421 application number: ANDA062421 ndc (product): 0591-5553
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	19d93cd3-6ac6-4e5d-8e7e-1a48799df3cf	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062421 application number: ANDA062421

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0440-7482	Doxycycline Hyclate	Doxycycline Hyclate	Liberty Pharmaceuticals, Inc.	ANDA	Current
0591-5553	Doxycycline Hyclate	Doxycycline Hyclate	Actavis Pharma, Inc.	ANDA	Current
0591-5553	Doxycycline Hyclate	Doxycycline Hyclate	Actavis Pharma, Inc.	ANDA	Current
0591-5553	Doxycycline Hyclate	Doxycycline Hyclate	Actavis Pharma, Inc.	ANDA	Current
0591-5553	Doxycycline Hyclate	Doxycycline Hyclate	Actavis Pharma, Inc.	ANDA	Current
0591-5553	Doxycycline Hyclate	Doxycycline Hyclate	Actavis Pharma, Inc.	ANDA	Current
50090-4867	Doxycycline Hyclate	Doxycycline Hyclate	A-S Medication Solutions	ANDA	Current
50090-4867	Doxycycline Hyclate	Doxycycline Hyclate	A-S Medication Solutions	ANDA	Current
55154-2653	Doxycycline Hyclate	Doxycycline Hyclate	Cardinal Health	ANDA	Current
63739-168	Doxycycline Hyclate	Doxycycline Hyclate	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-168	Doxycycline Hyclate	Doxycycline Hyclate	McKesson Corporation	ANDA	Current
63739-168	Doxycycline Hyclate	Doxycycline Hyclate	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-168	Doxycycline Hyclate	Doxycycline Hyclate	McKesson Corporation dba SKY Packaging	ANDA	Current