Application 065356

Type: ANDA
Sponsor: SUN PHARM INDS LTD

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
004	DOXYCYCLINE	DOXYCYCLINE	TABLET;ORAL	EQ 150MG 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A065356-001	DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2006-05-31
A065356-002	DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2006-05-31
A065356-003	DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2006-05-31
A065356-004	DOXYCYCLINE	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2010-07-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A065356-001	AB
A065356-002	AB
A065356-003	AB
A065356-004	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 5 · 164 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	A065356-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2006-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065356-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2006-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065356-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2006-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065356-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2010-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065356-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2006-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065356-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2006-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065356-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2006-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065356-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2010-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065356-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2006-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065356-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2006-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065356-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2006-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065356-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2010-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065356-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2006-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065356-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2006-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065356-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2006-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065356-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2010-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065356-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2006-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065356-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2006-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065356-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2006-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065356-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2010-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065356-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2006-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065356-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2006-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065356-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2006-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065356-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2010-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065356-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2006-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065356-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2006-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065356-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2006-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065356-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2010-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065356-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2006-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065356-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2006-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065356-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2006-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065356-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2010-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065356-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2006-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065356-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2006-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065356-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2006-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065356-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2010-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065356-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2006-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065356-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2006-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065356-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2006-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065356-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2010-07-29	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A065356-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065356-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065356-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065356-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065356-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065356-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065356-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065356-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065356-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065356-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065356-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065356-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065356-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065356-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065356-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065356-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065356-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065356-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065356-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065356-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065356-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065356-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065356-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065356-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065356-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065356-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065356-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065356-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065356-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065356-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065356-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065356-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065356-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065356-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065356-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065356-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065356-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065356-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065356-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065356-004	AB	1	`d06236e962d9…`

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
Doxycycline	DOXYCYCLINE	Sun Pharmaceutical Industries Inc.	8224b9c5-5c4b-4dda-bc58-47b6604c2884	2018-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065356 application number: ANDA065356 ndc (product): 63304-131 ndc (product): 63304-173 ndc (product): 63304-130 ndc (product): 63304-132

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
63304-130	Doxycycline	Doxycycline	Sun Pharmaceutical Industries Inc.	ANDA	Current
63304-131	Doxycycline	Doxycycline	Sun Pharmaceutical Industries Inc.	ANDA	Current
63304-132	Doxycycline	Doxycycline	Sun Pharmaceutical Industries Inc.	ANDA	Current
63304-173	Doxycycline	Doxycycline	Sun Pharmaceutical Industries Inc.	ANDA	Current