Application 065377

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXYCYCLINE	DOXYCYCLINE	TABLET;ORAL	EQ 50MG BASE	No	No
002	DOXYCYCLINE	DOXYCYCLINE	TABLET;ORAL	EQ 75MG BASE	No	No
003	DOXYCYCLINE	DOXYCYCLINE	TABLET;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
A065377-001	DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	2006-11-07
A065377-002	DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	2006-11-07
A065377-003	DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	2006-11-07

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 4 · 129 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	A065377-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	2006-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065377-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	2006-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065377-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	2006-11-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065377-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	2006-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065377-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	2006-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065377-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	2006-11-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065377-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	2006-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065377-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	2006-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065377-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	2006-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065377-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	2006-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065377-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	2006-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065377-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	2006-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065377-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	2006-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065377-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	2006-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065377-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	2006-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065377-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	2006-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065377-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	2006-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065377-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	2006-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065377-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	2006-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065377-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	2006-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065377-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	2006-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065377-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	2006-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065377-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	2006-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065377-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	2006-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065377-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	2006-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065377-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	2006-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065377-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	2006-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065377-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	2006-11-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065377-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	2006-11-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065377-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	2006-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065377-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	2006-11-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065377-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	2006-11-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065377-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	2006-11-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065377-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	2006-11-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065377-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	2006-11-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065377-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	2006-11-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065377-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	2006-11-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065377-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	2006-11-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065377-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	2006-11-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065377-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	2006-11-07	`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 2 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline	DOXYCYCLINE	American Health Packaging	e49f8ff9-af7a-47eb-929b-238cff381c03	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Preferred Pharmaceuticals Inc.	7f882f1a-fe75-4592-9df5-f0e4bf1d232e	2026-04-08	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Meitheal Pharmaceuticals Inc.	7772e702-20b3-473a-8bd5-9c7c92e753c6	2026-04-07	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	PD-Rx Pharmaceuticals, Inc.	7028b7f9-21cd-4c8e-97aa-a3e7d849939b	2026-03-27	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	PD-Rx Pharmaceuticals, Inc.	dedebcb4-3c3f-4487-a488-36af12640c92	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	DIRECT RX	31512ece-cb16-2a9a-e054-00144ff88e88	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	American Health Packaging	3fbf4bb8-036e-41d3-9628-476fc05ddd31	2026-02-23	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	A-S Medication Solutions	1c998ca8-1df6-4b3c-9533-f4500cc1079a	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	A-S Medication Solutions	2c7795c9-9e4e-477a-ad9f-01e4c55c06b6	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	6285181d-e34d-4def-abe6-2c41254ada75	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	JVET PHARMACEUTICALS LLC	ed95709e-2a1a-4deb-88bd-5b99f02b7a26	2026-01-27	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	Par Health USA, LLC	acb84610-5e26-4b0c-89e5-42bc0f8fa00d	2026-01-14	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	AiPing Pharmaceutical, Inc.	a894f4be-19e5-4785-8d0b-5e0d5626300e	2026-01-12	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	AvPAK	a5b28a41-db12-af7c-e053-2995a90ace09	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Proficient Rx LP	112c35d6-a397-45de-a57a-6e687cb27b4f	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Northwind Health Company, LLC	f2f1ee15-9323-1263-e053-2995a90a01fa	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	Northwind Health Company, LLC	f3319f4f-b535-da12-e053-2995a90ac00f	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE generic name: DOXYCYCLINE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Health Department, Oklahoma State	f39365f9-eb64-00cb-e053-2995a90a8d80	2025-12-31	Warnings	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Chartwell RX, LLC	5bebf320-1395-43b9-9404-fe479d70b240	2025-12-09	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Strides Pharma Science Limited	3b9888a2-ca16-43f7-ab6d-f03188ec2c0d	2025-12-02	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-6021	Doxycycline	Doxycycline	Mylan Pharmaceuticals Inc	ANDA	Current
0378-6022	Doxycycline	Doxycycline	Mylan Pharmaceuticals Inc	ANDA	Current
0378-6023	Doxycycline	Doxycycline	Mylan Pharmaceuticals Inc	ANDA	Current
0378-6023	Doxycycline	Doxycycline	Mylan Pharmaceuticals Inc.	ANDA	Current