Application 050278

Type: NDA
Sponsor: AVET

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACHROMYCIN V	TETRACYCLINE HYDROCHLORIDE	CAPSULE;ORAL	500MG	Yes	Yes
003	ACHROMYCIN V	TETRACYCLINE HYDROCHLORIDE	CAPSULE;ORAL	250MG	Yes	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
N050278-001	ACHROMYCIN V	TETRACYCLINE HYDROCHLORIDE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, Approved before 1982
N050278-003	ACHROMYCIN V	TETRACYCLINE HYDROCHLORIDE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050278-001	AB
N050278-003	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050278-001	ACHROMYCIN V	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050278-003	ACHROMYCIN V	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050278-001	ACHROMYCIN V	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050278-003	ACHROMYCIN V	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050278-001	ACHROMYCIN V	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050278-003	ACHROMYCIN V	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050278-001	ACHROMYCIN V	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050278-003	ACHROMYCIN V	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050278-001	ACHROMYCIN V	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050278-003	ACHROMYCIN V	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050278-001	ACHROMYCIN V	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050278-003	ACHROMYCIN V	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050278-001	ACHROMYCIN V	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050278-003	ACHROMYCIN V	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050278-001	ACHROMYCIN V	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050278-003	ACHROMYCIN V	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050278-001	ACHROMYCIN V	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050278-003	ACHROMYCIN V	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050278-001	ACHROMYCIN V	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050278-003	ACHROMYCIN V	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050278-001	ACHROMYCIN V	500MG	CAPSULE / ORAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050278-003	ACHROMYCIN V	250MG	CAPSULE / ORAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050278-001	ACHROMYCIN V	500MG	CAPSULE / ORAL		RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050278-003	ACHROMYCIN V	250MG	CAPSULE / ORAL		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050278-001	ACHROMYCIN V	500MG	CAPSULE / ORAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050278-003	ACHROMYCIN V	250MG	CAPSULE / ORAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050278-001	ACHROMYCIN V	500MG	CAPSULE / ORAL		RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050278-003	ACHROMYCIN V	250MG	CAPSULE / ORAL		RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050278-001	ACHROMYCIN V	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050278-003	ACHROMYCIN V	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050278-001	ACHROMYCIN V	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050278-003	ACHROMYCIN V	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050278-001	ACHROMYCIN V	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050278-003	ACHROMYCIN V	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050278-001	ACHROMYCIN V	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050278-003	ACHROMYCIN V	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050278-001	ACHROMYCIN V	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050278-003	ACHROMYCIN V	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050278-001	ACHROMYCIN V	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050278-003	ACHROMYCIN V	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 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	N050278-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050278-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050278-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050278-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050278-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050278-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050278-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050278-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050278-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050278-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050278-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050278-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050278-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050278-003	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050278-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050278-003	AB	1	`d8e5a09893c0…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050278-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050278-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050278-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050278-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050278-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050278-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050278-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050278-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050278-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050278-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050278-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050278-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050278-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050278-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050278-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050278-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050278-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050278-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050278-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050278-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050278-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050278-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050278-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050278-003	AB	1	`b00525d2431f…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
tetracycline hydrochloride	TETRACYCLINE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	eaa5b1bd-0927-46e4-b941-32fcc492d258	2025-03-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050278 application number: NDA050278 ndc (product): 23155-017 ndc (product): 23155-018

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
23155-017	tetracycline hydrochloride	tetracycline hydrochloride	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	NDA	Current
23155-017	tetracycline hydrochloride	tetracycline hydrochloride	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	NDA	Current
23155-017	Tetracycline Hydrochloride	Tetracycline Hydrochloride	Heritage Pharmaceuticals Inc.	NDA	Current
23155-018	tetracycline hydrochloride	tetracycline hydrochloride	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	NDA	Current
23155-018	tetracycline hydrochloride	tetracycline hydrochloride	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	NDA	Current
23155-018	Tetracycline Hydrochloride	Tetracycline Hydrochloride	Heritage Pharmaceuticals Inc.	NDA	Current
23155-487	Achromycin V	Tetracycline HCl	Heritage Pharmaceuticals Inc.	NDA	Current
23155-488	Achromycin V	Tetracycline HCl	Heritage Pharmaceuticals Inc.	NDA	Current
42291-798	Tetracycline Hydrochloride	Tetracycline Hydrochloride	AvKARE, Inc.	NDA	Current
42291-798	Tetracycline Hydrochloride	Tetracycline Hydrochloride	AvKARE	NDA	Current
42291-799	Tetracycline Hydrochloride	Tetracycline Hydrochloride	AvKARE, Inc.	NDA	Current
42291-799	Tetracycline Hydrochloride	Tetracycline Hydrochloride	AvKARE	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81848	SUPPL	2025-04-08
81795	SUPPL	2025-04-02
17815	SUPPL	2015-05-12
7722	SUPPL	2015-04-29