Application 060469

Type: ANDA
Sponsor: IMPAX LABS

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	100MG	No	No
003	TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	CAPSULE;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
A060469-001	TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	Approved before 1982
A060469-002	TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	Approved before 1982
A060469-003	TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	Approved before 1982

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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060469-002	TETRACYCLINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060469-003	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060469-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060469-002	TETRACYCLINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060469-003	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060469-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060469-002	TETRACYCLINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060469-003	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A060469-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A060469-002	TETRACYCLINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A060469-003	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060469-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060469-002	TETRACYCLINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060469-003	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A060469-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A060469-002	TETRACYCLINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A060469-003	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A060469-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A060469-002	TETRACYCLINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A060469-003	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A060469-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A060469-002	TETRACYCLINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A060469-003	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A060469-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A060469-002	TETRACYCLINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A060469-003	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A060469-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A060469-002	TETRACYCLINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A060469-003	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A060469-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A060469-002	TETRACYCLINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A060469-003	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A060469-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A060469-002	TETRACYCLINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A060469-003	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A060469-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A060469-002	TETRACYCLINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A060469-003	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A060469-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A060469-002	TETRACYCLINE HYDROCHLORIDE	100MG	CAPSULE / ORAL	Approved before 1982	`c0c555d07b60…`

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 2 · 26 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	Name fallback brand name: Tetracycline Hydrochloride generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc. .	ccd30048-a226-455f-971b-5dbf14b22e9d	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: Tetracycline Hydrochloride generic name: TETRACYCLINE HYDROCHLORIDE
Vitastem-tetracycline hydrochloride	TETRACYCLINE HYDROCHLORIDE	ViaDerma Distribution, Inc.	7ffe82a4-864b-48c7-9307-d262f20ca01e	2026-05-26	Warnings	Name fallback generic name: TETRACYCLINE HYDROCHLORIDE
Viaderma Vitastem First Aid Topical Antibiotic	TETRACYCLINE HYDROCHLORIDE	VIADERMA DISTRIBUTION INC	6eb04a76-7995-4df6-9c9b-dd450537e538	2026-05-26	Warnings	Name fallback generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Breckenridge Pharmaceutical, Inc.	00acf413-c5d2-4a54-9d0d-56266cbc9edc	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: Tetracycline Hydrochloride generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	22208459-3e6f-46a7-9f7f-f2c254a38132	2026-05-12	Warnings, Adverse reactions	Name fallback brand name: Tetracycline Hydrochloride generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Proficient Rx LP	d48071a0-c397-42f8-b8ad-158282e745e3	2026-05-01	Warnings, Adverse reactions	Name fallback brand name: Tetracycline Hydrochloride generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	b504e612-5aef-47fa-8f7b-dfb754011b9f	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: Tetracycline Hydrochloride generic name: TETRACYCLINE HYDROCHLORIDE
ViaDerma Care Tetracycline HCl First Aid Antibiotic	TETRACYCLINE HYDROCHLORIDE	ViaDerma Distribution, Inc.	5437777e-7f2b-412d-a2f5-380c09de4b1d	2026-01-14	Warnings	Name fallback generic name: TETRACYCLINE HYDROCHLORIDE
Vitastem First Aid Antibiotic	TETRACYCLINE HYDROCHLORIDE	VIADERMA DISTRIBUTION INC	3970ac49-ab0f-4492-ba61-95a12faed500	2025-12-02	Warnings	Name fallback generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	3ce3e8dc-7fbd-4f8d-a65f-092e1ef21725	2025-11-06	Warnings, Adverse reactions	Name fallback brand name: Tetracycline Hydrochloride generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	ae29aa18-6efb-47c9-bbd7-cbe8af1b7f38	2025-04-24	Warnings, Adverse reactions	Name fallback brand name: Tetracycline Hydrochloride generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Actavis Pharma, Inc.	32a409a0-fea6-411a-8218-c1c7df46d664	2025-04-09	Warnings, Adverse reactions	Name fallback brand name: Tetracycline Hydrochloride generic name: TETRACYCLINE HYDROCHLORIDE
Honestly Battleborn First Aid for Real Man	TETRACYCLINE HYDROCHLORIDE	HONESTLY LLC	13c1f2df-ba52-45e0-8868-a7518e9cdb55	2025-04-07	Warnings	Name fallback generic name: TETRACYCLINE HYDROCHLORIDE
Honestly Battleborn First Aid for Real Man	TETRACYCLINE HYDROCHLORIDE	HONESTLY LLC	93a6e02e-9f4b-4821-afa2-2029769f3088	2025-04-07	Warnings	Name fallback generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	4202cbfb-52e9-47f2-bd3a-1003319ca3cb	2025-03-24	Warnings, Adverse reactions	Name fallback brand name: Tetracycline Hydrochloride generic name: TETRACYCLINE HYDROCHLORIDE
tetracycline hydrochloride	TETRACYCLINE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	eaa5b1bd-0927-46e4-b941-32fcc492d258	2025-03-18	Warnings, Adverse reactions	Name fallback brand name: tetracycline hydrochloride generic name: TETRACYCLINE HYDROCHLORIDE
Vitastem	TETRACYCLINE HYDROCHLORIDE	ViaDerma Distribution, Inc.	a6630858-7038-425f-8a75-bb25f36a0dbe	2025-02-18	Warnings	Name fallback generic name: TETRACYCLINE HYDROCHLORIDE
Tetracyte Topical Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	VIADERMA DISTRIBUTION INC	0961b097-ba41-40c2-aaec-dd291841bf09	2025-01-30	Warnings	Name fallback generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	58e4b5b3-e093-46e7-b28e-a2c4821c5b63	2024-11-12	Warnings, Adverse reactions	Name fallback brand name: Tetracycline Hydrochloride generic name: TETRACYCLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.