Application 062752

Type: ANDA
Sponsor: CHARTWELL TETRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	CAPSULE;ORAL	250MG	No	No
002	TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	CAPSULE;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A062752-001	TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		1988-08-12
A062752-002	TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB		1988-08-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062752-001	AB
A062752-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A062752-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062752-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062752-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062752-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062752-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062752-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062752-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062752-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062752-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062752-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062752-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062752-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062752-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062752-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062752-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062752-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062752-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062752-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062752-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062752-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062752-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062752-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062752-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062752-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062752-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062752-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062752-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062752-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062752-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062752-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062752-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062752-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062752-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062752-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062752-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062752-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062752-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062752-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062752-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062752-002	AB	1	`bb7c543d1eb4…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	02e88b4a-57ae-4ef6-ba48-97c657202b94	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062752 application number: ANDA062752
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc. .	ccd30048-a226-455f-971b-5dbf14b22e9d	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062752 application number: ANDA062752
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	22208459-3e6f-46a7-9f7f-f2c254a38132	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062752 application number: ANDA062752
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Proficient Rx LP	d48071a0-c397-42f8-b8ad-158282e745e3	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062752 application number: ANDA062752
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	3ce3e8dc-7fbd-4f8d-a65f-092e1ef21725	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062752 application number: ANDA062752 ndc (product): 23155-766 ndc (product): 23155-767
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Chartwell RX, LLC.	aa30113f-ab58-4f41-82c1-2fcb540d4a82	2023-07-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062752 application number: ANDA062752 ndc (product): 62135-266 ndc (product): 62135-225

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-766	Tetracycline Hydrochloride	Tetracycline Hydrochloride	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-767	Tetracycline Hydrochloride	Tetracycline Hydrochloride	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
47781-508	Tetracycline Hydrochloride	Tetracycline Hydrochloride	Alvogen Inc.	ANDA	Current
47781-508	Tetracycline Hydrochloride	Tetracycline Hydrochloride	Alvogen Inc.	ANDA	Current
47781-509	Tetracycline Hydrochloride	Tetracycline Hydrochloride	Alvogen Inc.	ANDA	Current
47781-509	Tetracycline Hydrochloride	Tetracycline Hydrochloride	Alvogen Inc.	ANDA	Current
62135-225	Tetracycline Hydrochloride	tetracycline hydrochloride	Chartwell RX, LLC.	ANDA	Current
62135-225	Tetracycline Hydrochloride	tetracycline hydrochloride	Chartwell RX, LLC	ANDA	Current
62135-225	Tetracycline Hydrochloride	tetracycline hydrochloride	Chartwell RX, LLC.	ANDA	Current
62135-266	Tetracycline Hydrochloride	tetracycline hydrochloride	Chartwell RX, LLC.	ANDA	Current
62135-266	Tetracycline Hydrochloride	tetracycline hydrochloride	Chartwell RX, LLC	ANDA	Current
62135-266	Tetracycline Hydrochloride	tetracycline hydrochloride	Chartwell RX, LLC.	ANDA	Current
67405-660	Tetracycline Hydrochloride	Tetracycline Hydrochloride	Harris Pharmaceutical, Inc	ANDA	Current
67405-661	Tetracycline Hydrochloride	Tetracycline Hydrochloride	Harris Pharmaceutical, Inc	ANDA	Current
71335-0066	Tetracycline Hydrochloride	Tetracycline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0066	Tetracycline Hydrochloride	Tetracycline Hydrochloride	Bryant Ranch Prepack	ANDA	Current