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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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