Application 062676

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	CAPSULE;ORAL	EQ 100MG BASE	No	No
002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	CAPSULE;ORAL	EQ 50MG 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062676-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1986-07-10
A062676-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1986-07-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A062676-001	AB
A062676-002	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 3 · 82 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	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A062676-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062676-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062676-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062676-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062676-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062676-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062676-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062676-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062676-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062676-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062676-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062676-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062676-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062676-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062676-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062676-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062676-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062676-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062676-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062676-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062676-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062676-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062676-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062676-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062676-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062676-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062676-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062676-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062676-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062676-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062676-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062676-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062676-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062676-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062676-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062676-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062676-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062676-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062676-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062676-002	AB	1	`782e0a99824c…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	0994d23a-f9e4-4c33-ba44-a1f4ae4a312c	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	b988f851-cc06-4570-9706-cf65d370bd8e	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676 ndc (product): 72789-277
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	35aa295e-ff1b-453b-8eeb-65bbeda3baa5	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	6e3d0691-c071-441c-9b00-22a380305066	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676 ndc (product): 70518-1248
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Sun Pharmaceutical Industries, Inc.	214a9cfe-a522-4022-81d4-e59f447401fe	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676 ndc (product): 53489-118 ndc (product): 53489-119
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	DIRECT RX	9798c4de-8af7-41c4-acc2-1e9775194297	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676 ndc (product): 61919-082
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	AvPAK	53ff9f7e-0db0-c841-d334-4cf31f658828	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676 ndc (product): 50268-277 ndc (product): 50268-278
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Advanced Rx Pharmacy of Tennessee, LLC	ecab47ea-d7b9-515d-e053-2995a90adc46	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676 ndc (product): 80425-0211
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Advanced Rx Pharmacy of Tennessee, LLC	f5ed9293-15f8-ecfa-e053-2a95a90ab6a4	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Quality Care Products, LLC	2a3b79e8-f14c-4b44-9d3e-3c92a82269bd	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	0fdc3d87-8819-4c2c-e063-6394a90a687b	2024-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	86c1f165-af79-4f01-ab61-3bdbce24cd0d	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676 ndc (product): 71205-653

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-060	Doxycycline Hyclate	Doxycycline Hyclate	Blenheim Pharmacal, Inc.	ANDA	Current
45865-444	Doxycycline Hyclate	Doxycycline Hyclate	Medsource Pharmaceuticals	ANDA	Current
45865-444	Doxycycline Hyclate	Doxycycline Hyclate	Medsource Pharmaceuticals	ANDA	Current
50090-0299	Doxycycline Hyclate	Doxycycline Hyclate	A-S Medication Solutions	ANDA	Current
50268-277	Doxycycline Hyclate	Doxycycline Hyclate	AvPAK	ANDA	Current
50268-277	Doxycycline Hyclate	Doxycycline Hyclate	AvPAK	ANDA	Current
50268-278	Doxycycline Hyclate	Doxycycline Hyclate	AvPAK	ANDA	Current
50268-278	Doxycycline Hyclate	Doxycycline Hyclate	AvPAK	ANDA	Current
53489-118	Doxycycline Hyclate	Doxycycline Hyclate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
53489-118	Doxycycline Hyclate	Doxycycline Hyclate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
53489-119	Doxycycline Hyclate	Doxycycline Hyclate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
53489-119	Doxycycline Hyclate	Doxycycline Hyclate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
61919-082	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	DIRECT RX	ANDA	Current
61919-907	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	DIRECT RX	ANDA	Current
61919-907	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	DIRECT RX	ANDA	Current
66336-558	Doxycycline Hyclate	Doxycycline Hyclate	Dispensing Solutions, Inc.	ANDA	Current
67046-130	Doxycycline Hyclate	Doxycycline Hyclate	Contract Pharmacy Services-PA	ANDA	Current
70518-1248	Doxycycline Hyclate	Doxycycline Hyclate	REMEDYREPACK INC.	ANDA	Current
70518-1248	Doxycycline Hyclate	Doxycycline Hyclate	REMEDYREPACK INC.	ANDA	Current
70518-1248	Doxycycline Hyclate	Doxycycline Hyclate	REMEDYREPACK INC.	ANDA	Current
70518-1248	Doxycycline Hyclate	Doxycycline Hyclate	REMEDYREPACK INC.	ANDA	Current
70518-1248	Doxycycline Hyclate	Doxycycline Hyclate	REMEDYREPACK INC.	ANDA	Current
70518-1248	Doxycycline Hyclate	Doxycycline Hyclate	REMEDYREPACK INC.	ANDA	Current
70934-810	Doxycycline Hyclate	Doxycycline Hyclate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-951	Doxycycline Hyclate	Doxycycline Hyclate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-653	Doxycycline Hyclate	Doxycycline Hyclate	Proficient Rx LP	ANDA	Current
72789-277	Doxycycline Hyclate	Doxycycline Hyclate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-277	Doxycycline Hyclate	Doxycycline Hyclate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
75921-119	Doxycycline Hyclate	Doxycycline Hyclate	Life Line Home Care Services, Inc.	ANDA	Current
80425-0211	Doxycycline Hyclate	Doxycycline Hyclate	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current