Application 213075

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, 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 150MG 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 1.

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
A213075-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03
A213075-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03
A213075-003	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03
A213075-004	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213075-001	AB
A213075-002	AB
A213075-003	AB
A213075-004	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 1 of 4 · 128 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	A213075-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213075-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213075-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213075-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213075-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213075-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213075-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213075-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213075-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213075-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213075-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213075-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213075-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213075-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213075-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213075-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213075-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213075-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213075-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213075-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213075-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213075-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213075-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213075-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213075-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213075-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213075-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213075-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213075-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213075-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213075-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213075-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213075-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213075-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213075-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213075-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213075-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213075-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213075-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213075-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 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	A213075-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213075-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213075-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213075-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213075-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213075-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213075-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213075-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213075-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213075-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213075-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213075-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213075-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213075-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213075-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213075-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213075-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213075-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213075-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213075-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213075-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213075-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213075-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213075-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213075-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213075-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213075-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213075-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213075-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213075-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213075-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213075-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213075-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213075-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213075-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213075-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213075-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213075-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213075-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213075-004	AB	1	`d06236e962d9…`

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.	3ae4ca12-be39-46b9-bc4c-f8356776c175	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213075 application number: ANDA213075 ndc (product): 62332-484 ndc (product): 62332-482 ndc (product): 62332-481 ndc (product): 62332-483
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Limited	44ac5de1-c0c6-4d58-9a49-b2dae60ea921	2023-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213075 application number: ANDA213075 ndc (product): 46708-482 ndc (product): 46708-484 ndc (product): 46708-483 ndc (product): 46708-481

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
46708-481	Doxycycline Hyclate	Doxycycline Hyclate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-482	Doxycycline Hyclate	Doxycycline Hyclate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-483	Doxycycline Hyclate	Doxycycline Hyclate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-484	Doxycycline Hyclate	Doxycycline Hyclate	Alembic Pharmaceuticals Limited	ANDA	Current
62332-481	Doxycycline Hyclate	Doxycycline Hyclate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-481	Doxycycline Hyclate	Doxycycline Hyclate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-482	Doxycycline Hyclate	Doxycycline Hyclate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-482	Doxycycline Hyclate	Doxycycline Hyclate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-483	Doxycycline Hyclate	Doxycycline Hyclate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-483	Doxycycline Hyclate	Doxycycline Hyclate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-484	Doxycycline Hyclate	Doxycycline Hyclate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-484	Doxycycline Hyclate	Doxycycline Hyclate	Alembic Pharmaceuticals Inc.	ANDA	Current