Application 062475

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXY 100	DOXYCYCLINE HYCLATE	INJECTABLE;INJECTION	EQ 100MG BASE/VIAL	No	Yes
002	DOXY 200	DOXYCYCLINE HYCLATE	INJECTABLE;INJECTION	EQ 200MG BASE/VIAL	No	Yes

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
A062475-001	DOXY 100	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09
A062475-002	DOXY 200	DOXYCYCLINE HYCLATE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062475-001	AP
A062475-002	AP

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062475-001	DOXY 100	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062475-002	DOXY 200	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1983-12-09	`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	A062475-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062475-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062475-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062475-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062475-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062475-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062475-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062475-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062475-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062475-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062475-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062475-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062475-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062475-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062475-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062475-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062475-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062475-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062475-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062475-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062475-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062475-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062475-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062475-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062475-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062475-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062475-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062475-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062475-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062475-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062475-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062475-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062475-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062475-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062475-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062475-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062475-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062475-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062475-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062475-002	AP	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOXY 100(TM) DOXYCYCLINE	DOXY 100(TM) DOXYCYCLINE	HF Acquisition Co LLC, DBA HealthFirst	9454f948-584f-59de-e053-2a95a90a9f01	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062475 application number: ANDA062475 ndc (product): 51662-1402
Doxy 100	DOXYCYCLINE	Fresenius Kabi USA, LLC	b256babb-1bba-4b0c-8837-d13ba3af7659	2021-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062475 application number: ANDA062475 ndc (product): 63323-130
Doxy 100	DOXYCYCLINE	Fresenius Kabi USA, LLC	a7b754e2-a028-469d-ba95-8412ef03ab0a	2021-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062475 application number: ANDA062475 ndc (product): 63323-130
Doxy 100	DOXYCYCLINE	Fresenius Kabi USA, LLC	b0894010-39bd-459f-8563-cf83343105ee	2020-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062475 application number: ANDA062475 ndc (product): 63323-130

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51662-1402	DOXY 100(TM) DOXYCYCLINE	DOXY 100(TM) DOXYCYCLINE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1402	DOXY 100(TM) DOXYCYCLINE	DOXY 100(TM) DOXYCYCLINE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1402	DOXY 100(TM) DOXYCYCLINE	DOXY 100(TM) DOXYCYCLINE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
52584-028	Doxy 100	Doxycycline	General Injectables & Vaccines, Inc	ANDA	Current
52584-028	Doxy 100	Doxycycline	General Injectables & Vaccines, Inc	ANDA	Current
63323-130	Doxy 100	DOXYCYCLINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-130	Doxy 100	DOXYCYCLINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-130	Doxy 100	DOXYCYCLINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-130	Doxy 100	DOXYCYCLINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-130	Doxy 100	DOXYCYCLINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-130	Doxy 100	DOXYCYCLINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-130	Doxy 100	DOXYCYCLINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-130	Doxy 100	DOXYCYCLINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-130	Doxy 100	DOXYCYCLINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-130	Doxy 100	DOXYCYCLINE	Fresenius Kabi USA, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18308	SUPPL	2014-01-31