Application 210536

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	TABLET;ORAL	EQ 100MG BASE	No	No
002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	TABLET;ORAL	EQ 50MG 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
A210536-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL			2020-05-14
A210536-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		2021-09-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210536-002	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 2 · 70 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	A210536-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		2020-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210536-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-09-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210536-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		2020-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210536-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-09-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210536-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		2020-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210536-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-09-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210536-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		2020-05-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210536-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-09-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210536-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		2020-05-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210536-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-09-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210536-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		2020-05-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210536-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-09-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210536-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		2020-05-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210536-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-09-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210536-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		2020-05-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210536-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-09-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210536-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		2020-05-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210536-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-09-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210536-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		2020-05-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210536-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-09-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210536-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		2020-05-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210536-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-09-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210536-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		2020-05-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210536-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-09-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210536-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		2020-05-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210536-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-09-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210536-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		2020-05-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210536-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-09-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210536-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		2020-05-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210536-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-09-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210536-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		2020-05-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210536-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-09-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210536-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		2020-05-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210536-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-09-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210536-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		2020-05-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210536-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-09-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210536-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		2020-05-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210536-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-09-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210536-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		2020-05-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210536-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		2020-05-14	`5aa47cf7b7d7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210536-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210536-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210536-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210536-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210536-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210536-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210536-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210536-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210536-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210536-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210536-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210536-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210536-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210536-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210536-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210536-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210536-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210536-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210536-002	AB	1	`782e0a99824c…`
2020-11-12 02:37 UTC	2020-11	A210536-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210536-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210536-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210536-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210536-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210536-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210536-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210536-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210536-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210536-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210536-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210536-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210536-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210536-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210536-002	AB	1	`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	Alembic Pharmaceuticals Inc.	cff08863-7156-49d0-abbd-8f9274302886	2025-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210536 application number: ANDA210536 ndc (product): 62332-499 ndc (product): 62332-353
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Limited	24c8472a-dd07-4f84-8bea-20a3f178d119	2023-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210536 application number: ANDA210536 ndc (product): 46708-353 ndc (product): 46708-499

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-353	Doxycycline Hyclate	Doxycycline Hyclate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-353	Doxycycline Hyclate	Doxycycline Hyclate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-499	Doxycycline Hyclate	Doxycycline Hyclate	Alembic Pharmaceuticals Limited	ANDA	Current
62332-353	Doxycycline Hyclate	Doxycycline Hyclate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-353	Doxycycline Hyclate	Doxycycline Hyclate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-353	Doxycycline Hyclate	Doxycycline Hyclate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-499	Doxycycline Hyclate	Doxycycline Hyclate	Alembic Pharmaceuticals Inc.	ANDA	Current