Application 065032

Type: ANDA
Sponsor: SANDOZ INC

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 100MG BASE	No	No

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

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
A065032-001	DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL			2000-06-30
A065032-002	DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL			2000-06-30

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A065032-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2000-06-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A065032-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2000-06-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A065032-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2000-06-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065032-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2000-06-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065032-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2000-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065032-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2000-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065032-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2000-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065032-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2000-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065032-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2000-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065032-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2000-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065032-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2000-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065032-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2000-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065032-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2000-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065032-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2000-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065032-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2000-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065032-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2000-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065032-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2000-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065032-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2000-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065032-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2000-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065032-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2000-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065032-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2000-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065032-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2000-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065032-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2000-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065032-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2000-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065032-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2000-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065032-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2000-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065032-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2000-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065032-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2000-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065032-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2000-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065032-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2000-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065032-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2000-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065032-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2000-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065032-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2000-06-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065032-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2000-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065032-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2000-06-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065032-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2000-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065032-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2000-06-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065032-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2000-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065032-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2000-06-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065032-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2000-06-30	`4b0b4de00fa7…`

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 4 of 5 · 100 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOXYCYCLINE	DOXYCYCLINE	Lupin Pharmaceuticals, Inc.	81c5a7fc-3fe0-40b2-bae0-c79eb0b27697	2025-06-04	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	b46208a2-5072-4df5-b2af-379f865545d2	2025-06-02	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	A-S Medication Solutions	2b3b3c48-eb60-400c-bdfe-50635a136c90	2025-05-28	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Zydus Pharmaceuticals USA Inc.	fef9580d-8850-4cbb-89eb-2b4d40ee59c9	2025-04-26	Warnings, Adverse reactions	Name fallback brand name: doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Sun Pharmaceutical Industries, Inc.	829dbd3d-5c2b-47b8-96a5-423af78c93b9	2025-04-24	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
ORACEA	DOXYCYCLINE	Galderma Laboratories, L.P.	aa15c93a-ff4c-447a-8a21-96da506d8997	2025-04-16	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	Mayne Pharma Inc.	0e6b3e17-aeee-4910-8e94-c7ac925b9cca	2025-04-15	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Alembic Pharmaceuticals Inc.	d77e2a9c-c536-4e66-b87a-40b085737699	2025-04-14	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Zydus Pharmaceuticals USA Inc.	bc321932-b600-4659-a499-1853991b4ab9	2025-04-10	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	FOSUN PHARMA USA INC	fa3fbb09-b830-60c5-e053-6394a90a4165	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Hikma Pharmaceuticals USA Inc.	2aa835bd-6fac-46b8-9716-9622fb550c8f	2025-03-25	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	Gland Pharma Limited	6a5780a9-4548-427c-972a-ef49fdcbc84d	2025-03-20	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Direct_Rx	8c273efa-62ec-16b2-e053-2995a90ac41d	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	American Health Packaging	adc6ba78-8dd7-47af-a7b4-c2215557696b	2025-01-02	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Mylan Institutional LLC	878a1cf9-31a9-425b-910d-042ed91e98d5	2025-01-02	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Zydus Pharmaceuticals USA Inc.	7ce80f6e-3c0d-4978-b626-5fd3f3ff349e	2025-01-01	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Amneal Pharmaceuticals LLC	95ba4d68-2519-4edd-b9a2-5cd2fd00b250	2024-12-05	Warnings, Adverse reactions	Name fallback brand name: Doxycycline generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Zydus Lifesciences Limited	aa01035d-8b4a-4fdc-bfdf-2b39df0d8fc9	2024-11-28		Name fallback brand name: doxycycline generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	Lupin Pharmaceuticals, Inc.	bcc65910-30d8-4807-ab61-607a56382924	2024-11-27	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	5f22094e-9297-4d1b-a37c-7846481b321e	2024-08-26	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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30630	ORIG	2000-06-30