Application 208942

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXYCYCLINE	DOXYCYCLINE	CAPSULE;ORAL	EQ 50MG BASE	No	No
002	DOXYCYCLINE	DOXYCYCLINE	CAPSULE;ORAL	EQ 75MG BASE	No	No
003	DOXYCYCLINE	DOXYCYCLINE	CAPSULE;ORAL	EQ 100MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A208942-001	DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2021-01-21
A208942-002	DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21
A208942-003	DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2021-01-21

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 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208942-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2021-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208942-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208942-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2021-01-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208942-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2021-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208942-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208942-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2021-01-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208942-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2021-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208942-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208942-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2021-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208942-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2021-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208942-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208942-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2021-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208942-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2021-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208942-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208942-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2021-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208942-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2021-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208942-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208942-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2021-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208942-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2021-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208942-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208942-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2021-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208942-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2021-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208942-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208942-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2021-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208942-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2021-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208942-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208942-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2021-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208942-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2021-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208942-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208942-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2021-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208942-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2021-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208942-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208942-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2021-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208942-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2021-01-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208942-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208942-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2021-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208942-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2021-01-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208942-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2021-01-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208942-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2021-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208942-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2021-01-21	`301d65b070ca…`

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 6 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
doxycycline	DOXYCYCLINE	Proficient Rx LP	f3ba6c30-ada3-4a57-9ff8-30558202b9aa	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Sun Pharmaceutical Industries Inc.	8224b9c5-5c4b-4dda-bc58-47b6604c2884	2018-08-06	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE

Reported adverse events (FAERS/openFDA)#

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