Application 065053

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	CAPSULE;ORAL	EQ 50MG BASE	No	No
002	DOXYCYCLINE	DOXYCYCLINE	CAPSULE;ORAL	EQ 100MG BASE	No	Yes
003	DOXYCYCLINE	DOXYCYCLINE	CAPSULE;ORAL	EQ 75MG 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065053-001	DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22
A065053-002	DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22
A065053-003	DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A065053-001	AB
A065053-002	AB
A065053-003	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A065053-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065053-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065053-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065053-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065053-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065053-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065053-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065053-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065053-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065053-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065053-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065053-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065053-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065053-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065053-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065053-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065053-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065053-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065053-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065053-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065053-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065053-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065053-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065053-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065053-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065053-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065053-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065053-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065053-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065053-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065053-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065053-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065053-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065053-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065053-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065053-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065053-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065053-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065053-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065053-001	AB	1	`8072bd15b7f6…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline	DOXYCYCLINE	Sun Pharmaceutical Industries, Inc.	829dbd3d-5c2b-47b8-96a5-423af78c93b9	2025-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065053 application number: ANDA065053 ndc (product): 63304-615 ndc (product): 63304-614 ndc (product): 63304-616
Doxycycline Monohydrate	DOXYCYCLINE MONOHYDRATE	Direct_Rx	dfef600c-bceb-fbc9-e053-2a95a90ae6c0	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065053 application number: ANDA065053 ndc (product): 72189-358
Doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	4b170180-21f4-4ee5-9e81-1607ab52cfca	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065053 application number: ANDA065053 ndc (product): 71335-1988

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5984	Doxycycline	Doxycycline	A-S Medication Solutions	ANDA	Current
53002-0673	Doxycycline	Doxycycline	RPK Pharmaceuticals, Inc.	ANDA	Current
63304-614	Doxycycline	Doxycycline	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-614	Doxycycline	Doxycycline	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-615	Doxycycline	Doxycycline	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-615	Doxycycline	Doxycycline	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-616	Doxycycline	Doxycycline	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-616	Doxycycline	Doxycycline	Sun Pharmaceutical Industries, Inc.	ANDA	Current
67296-1688	Doxycycline	Doxycycline	RedPharm Drug, Inc.	ANDA	Current
67296-1688	Doxycycline	Doxycycline	RedPharm Drug, Inc.	ANDA	Current
67296-1688	Doxycycline	Doxycycline	RedPharm Drug, Inc.	ANDA	Current
70934-499	Doxycycline	Doxycycline	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-1988	Doxycycline	Doxycycline	Bryant Ranch Prepack	ANDA	Current
72189-358	Doxycycline Monohydrate	Doxycycline Monohydrate	Direct_Rx	ANDA	Current
72789-047	Doxycycline	Doxycycline	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-047	Doxycycline	Doxycycline	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-047	Doxycycline	Doxycycline	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-047	Doxycycline	Doxycycline	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-047	Doxycycline	Doxycycline	PD-Rx Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30639	ORIG	2000-11-22