Application 210527

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	CAPSULE;ORAL	EQ 50MG BASE	No	No
002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	CAPSULE;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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210527-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		2018-06-13
A210527-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2018-06-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A210527-001	AB
A210527-002	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 3 · 82 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	A210527-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210527-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210527-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210527-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210527-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210527-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210527-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210527-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210527-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210527-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210527-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210527-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210527-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210527-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210527-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210527-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210527-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-06-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210527-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210527-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-06-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210527-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210527-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-06-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210527-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210527-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-06-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210527-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210527-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-06-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210527-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210527-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-06-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210527-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210527-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-06-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210527-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210527-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-06-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210527-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210527-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-06-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210527-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210527-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-06-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210527-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210527-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-06-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210527-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210527-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-06-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210527-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-06-13	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A210527-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210527-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210527-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210527-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210527-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210527-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210527-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210527-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210527-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210527-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210527-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210527-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210527-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210527-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210527-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210527-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210527-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210527-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210527-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210527-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210527-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210527-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210527-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210527-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210527-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210527-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210527-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210527-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210527-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210527-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210527-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210527-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210527-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210527-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210527-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210527-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210527-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210527-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210527-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210527-002	AB	1	`782e0a99824c…`

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	Alembic Pharmaceuticals Inc.	131af052-0c4f-4a61-ae9a-e6165ae09076	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210527 application number: ANDA210527 ndc (product): 62332-363 ndc (product): 62332-362
doxycycline hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Limited	e567b431-53fe-4e27-9b05-bf6eeb8abb51	2023-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210527 application number: ANDA210527 ndc (product): 46708-362 ndc (product): 46708-363

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-362	doxycycline hyclate	doxycycline hyclate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-362	doxycycline hyclate	doxycycline hyclate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-363	doxycycline hyclate	doxycycline hyclate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-363	doxycycline hyclate	doxycycline hyclate	Alembic Pharmaceuticals Limited	ANDA	Current
62332-362	doxycycline hyclate	doxycycline hyclate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-362	doxycycline hyclate	doxycycline hyclate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-362	doxycycline hyclate	doxycycline hyclate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-362	doxycycline hyclate	doxycycline hyclate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-363	doxycycline hyclate	doxycycline hyclate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-363	doxycycline hyclate	doxycycline hyclate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-363	doxycycline hyclate	doxycycline hyclate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-363	doxycycline hyclate	doxycycline hyclate	Alembic Pharmaceuticals Inc.	ANDA	Current