Application 062538

Type: ANDA
Sponsor: VINTAGE PHARMS

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
A062538-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		1986-04-07
A062538-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		2025-11-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062538-001	AB
A062538-002	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 · 44 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	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062538-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2025-11-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062538-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2025-11-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062538-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		1986-04-07	`f41ea6bd6efb…`

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	A062538-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062538-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062538-002	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A062538-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A062538-002	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	Strides Pharma Science Limited	2deeee4f-b342-a178-e063-6394a90af897	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062538 application number: ANDA062538
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Strides Pharma Science Limited	b8b76aaa-575b-497f-b854-c42bc992c784	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062538 application number: ANDA062538