Application 214596

Type: ANDA
Sponsor: CIPLA USA INC.

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHYTONADIONE	PHYTONADIONE	INJECTABLE;INJECTION	1MG/0.5ML	No	No
002	PHYTONADIONE	PHYTONADIONE	INJECTABLE;INJECTION	10MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A214596-001	PHYTONADIONE	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	AB2	RS	2022-04-22
A214596-002	PHYTONADIONE	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214596-001	AB2

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 · 60 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
2026-08-18 06:07:40	2026-07	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	AB2	RS	2022-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	AB2		2022-04-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION	AB2		2022-04-22	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214596-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION		RS	2022-04-22	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214596-002	PHYTONADIONE	10MG/ML	INJECTABLE / INJECTION		RS	2022-04-22	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214596-001	AB2	1	`caaa826d4ba7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214596-001	AB2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214596-002	AB2	1	`5c6f7cd8ea54…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214596-001	AB2	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214596-002	AB2	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214596-001	AB2	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214596-001	CGT	2022-10-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214596-002	CGT	2022-10-30	`5c6f7cd8ea54…`
2023-01-26 05:58 UTC	2023-01	A214596-001	CGT	2022-10-30	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214596-002	CGT	2022-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214596-001	CGT	2022-10-30	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214596-002	CGT	2022-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214596-001	CGT	2022-10-30	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A214596-002	CGT	2022-10-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214596-001	CGT	2022-10-30	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A214596-002	CGT	2022-10-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214596-001	CGT	2022-10-30	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214596-002	CGT	2022-10-30	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phytonadione	PHYTONADIONE	Cipla USA Inc.	1add4de5-0f9c-453e-9dd5-abb8077b566a	2024-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214596 application number: ANDA214596 ndc (product): 69097-708 ndc (product): 69097-709

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69097-708	Phytonadione	Phytonadione	Cipla USA Inc.	ANDA	Current
69097-709	Phytonadione	Phytonadione	Cipla USA Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71922	ORIG	2022-08-26