Application 062677

Type: ANDA
Sponsor: SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	TABLET;ORAL	EQ 100MG 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062677-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		1986-07-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062677-001	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 2 · 41 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	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A062677-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062677-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062677-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062677-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062677-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062677-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062677-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062677-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062677-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062677-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062677-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062677-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062677-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062677-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062677-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062677-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062677-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062677-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062677-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062677-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062677-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062677-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062677-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062677-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062677-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062677-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062677-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062677-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062677-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062677-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062677-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062677-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062677-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062677-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062677-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062677-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062677-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062677-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062677-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062677-001	AB	1	`cb3db0bc1861…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	c8194d6e-c407-465e-a342-4d2d9756dfc4	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062677 application number: ANDA062677 ndc (product): 70518-3213
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	cf95b2ca-2cf8-49a8-8e3a-f9b0f5b2072c	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062677 application number: ANDA062677
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	3af9348c-a98b-4059-a5ef-4229e2b33af0	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062677 application number: ANDA062677
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	1401d590-0967-4c6b-b52b-a83e9f6df097	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062677 application number: ANDA062677 ndc (product): 72789-276
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Sun Pharmaceutical Industries, Inc.	214a9cfe-a522-4022-81d4-e59f447401fe	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062677 application number: ANDA062677 ndc (product): 53489-120
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	AvPAK	53ff9f7e-0db0-c841-d334-4cf31f658828	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062677 application number: ANDA062677 ndc (product): 50268-279

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
15338-744	Doxycycline Hyclate	Doxycycline Hyclate	Apace Packaging, LLC	ANDA	Current
43353-923	Doxycycline Hyclate	Doxycycline Hyclate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-0023	Doxycycline Hyclate	Doxycycline Hyclate	A-S Medication Solutions	ANDA	Current
50090-0023	Doxycycline Hyclate	Doxycycline Hyclate	A-S Medication Solutions	ANDA	Current
50090-0023	Doxycycline Hyclate	Doxycycline Hyclate	A-S Medication Solutions	ANDA	Current
50268-279	Doxycycline Hyclate	Doxycycline Hyclate	AvPAK	ANDA	Current
50268-279	Doxycycline Hyclate	Doxycycline Hyclate	AvPAK	ANDA	Current
53401-300	Doxycycline Hyclate	Doxycycline Hyclate	Aphena Pharma Solutions - New Jersey, LLC	ANDA	Current
53489-120	Doxycycline Hyclate	Doxycycline Hyclate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
53489-120	Doxycycline Hyclate	Doxycycline Hyclate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
55695-032	Doxycycline Hyclate	Doxycycline Hyclate	Department of State Health Services, Pharmacy Branch	ANDA	Current
63629-6880	Doxycycline Hyclate	Doxycycline Hyclate	Bryant Ranch Prepack	ANDA	Current
63629-6880	Doxycycline Hyclate	Doxycycline Hyclate	Bryant Ranch Prepack	ANDA	Current
67296-0329	Doxycycline Hyclate	Doxycycline Hyclate	RedPharm Drug, Inc.	ANDA	Current
70518-3213	Doxycycline Hyclate	Doxycycline Hyclate	REMEDYREPACK INC.	ANDA	Current
72789-276	Doxycycline Hyclate	Doxycycline Hyclate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-276	Doxycycline Hyclate	Doxycycline Hyclate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-276	Doxycycline Hyclate	Doxycycline Hyclate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current