Application 207773

Type: ANDA
Sponsor: CADILA

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
A207773-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2017-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207773-001	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	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`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	A207773-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207773-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207773-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207773-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207773-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207773-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207773-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207773-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207773-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207773-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207773-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207773-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207773-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207773-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207773-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207773-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207773-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207773-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207773-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207773-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207773-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207773-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207773-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207773-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207773-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207773-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207773-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207773-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207773-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207773-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207773-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207773-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207773-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207773-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207773-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207773-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207773-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207773-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207773-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207773-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	RedPharm Drug, Inc.	bdacaaa7-b46e-ee0c-e053-2a95a90aea3c	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207773 application number: ANDA207773 ndc (product): 67296-1431
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Viona Pharmaceuticals Inc	763997f0-b35c-43cb-a792-3e0bae589536	2025-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207773 application number: ANDA207773 ndc (product): 72578-001
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	5b4390ed-a0ec-4ef8-864c-8a33a83653f9	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207773 application number: ANDA207773 ndc (product): 71335-2113
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NCS HealthCare of KY, LLC dba Vangard Labs	104cac0f-7c99-4faf-ba08-0159ed767a3e	2024-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207773 application number: ANDA207773
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Zydus Lifesciences Limited	68b3aba5-f1e4-4cdf-b244-0302aa8595fe	2024-08-16		Exact identifier application applno (ANDA): 207773 application number: ANDA207773 ndc (product): 70771-1104

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60760-651	Doxycycline Hyclate	Doxycycline Hyclate	ST. MARY'S MEDICAL PARK PHARMACY	ANDA	Current
67296-1431	Doxycycline Hyclate	Doxycycline Hyclate	RedPharm Drug, Inc.	ANDA	Current
68382-211	Doxycycline hyclate	Doxycycline hyclate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68788-8217	Doxycycline Hyclate	Doxycycline Hyclate	Preferred Pharmaceuticals Inc	ANDA	Current
70771-1104	Doxycycline hyclate	Doxycycline hyclate	Cadila Healthcare Limited	ANDA	Current
70771-1104	Doxycycline hyclate	Doxycycline hyclate	Cadila Healthcare Limited	ANDA	Current
70771-1104	Doxycycline hyclate	Doxycycline hyclate	Cadila Healthcare Limited	ANDA	Current
70771-1104	Doxycycline hyclate	Doxycycline hyclate	Zydus Lifesciences Limited	ANDA	Current
71335-2113	Doxycycline Hyclate	Doxycycline Hyclate	Bryant Ranch Prepack	ANDA	Current
71335-2113	Doxycycline Hyclate	Doxycycline Hyclate	Bryant Ranch Prepack	ANDA	Current
72578-001	Doxycycline Hyclate	Doxycycline Hyclate	Viona Pharmaceuticals Inc	ANDA	Current
72578-001	Doxycycline Hyclate	Doxycycline Hyclate	Viona Pharmaceuticals Inc	ANDA	Current
72578-001	Doxycycline Hyclate	Doxycycline Hyclate	Viona Pharmaceuticals Inc	ANDA	Current