Application 020793

Type: NDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CAFCIT	CAFFEINE CITRATE	SOLUTION;INTRAVENOUS	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	Yes	Yes
002	CAFCIT	CAFFEINE CITRATE	SOLUTION;ORAL	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	Yes	Yes

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
N020793-001	CAFCIT	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1999-09-21
N020793-002	CAFCIT	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2000-04-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020793-001	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 · 84 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	N020793-001	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1999-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020793-002	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2000-04-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020793-001	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1999-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020793-002	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2000-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020793-001	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1999-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020793-002	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2000-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020793-001	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1999-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020793-002	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2000-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020793-001	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1999-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020793-002	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2000-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020793-001	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1999-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020793-002	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2000-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020793-001	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1999-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020793-002	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2000-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020793-001	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1999-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020793-002	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2000-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020793-001	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1999-09-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020793-002	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2000-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020793-001	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1999-09-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020793-002	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2000-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020793-001	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1999-09-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020793-002	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2000-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020793-001	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1999-09-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020793-002	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2000-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020793-001	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1999-09-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020793-002	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2000-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020793-001	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1999-09-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020793-002	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2000-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020793-001	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1999-09-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020793-002	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2000-04-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020793-001	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1999-09-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020793-002	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / ORAL		RLD	2000-04-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020793-001	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1999-09-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020793-002	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / ORAL		RLD	2000-04-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020793-001	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1999-09-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020793-002	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / ORAL		RLD	2000-04-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020793-001	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1999-09-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020793-002	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / ORAL	AA	RLD, RS	2000-04-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020793-001	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1999-09-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020793-002	CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / ORAL		RLD	2000-04-12	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020793-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020793-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020793-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020793-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020793-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020793-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020793-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020793-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020793-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020793-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020793-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020793-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020793-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020793-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020793-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020793-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020793-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020793-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020793-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020793-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020793-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020793-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020793-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020793-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020793-002	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020793-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020793-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020793-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020793-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020793-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020793-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020793-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020793-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020793-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020793-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020793-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020793-002	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020793-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020793-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020793-001	AP	1	`ea1830bbd6c7…`

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
Caffeine Citrate	CAFFEINE CITRATE	Hikma Pharmaceuticals USA Inc.	21489401-f2a7-47d3-897a-4b7efa04dd7a	2024-04-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020793 application number: NDA020793

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
0641-6164	CAFCIT	caffeine citrate	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6164	CAFCIT	caffeine citrate	Hikma Pharmaceuticals USA Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62031	SUPPL	2020-03-04
62025	SUPPL	2020-03-04
35383	SUPPL	2015-12-22
25855	SUPPL	2010-06-16
20964	ORIG	2005-07-15
3381	SUPPL	2002-02-08
3380	SUPPL	2002-01-18
35382	SUPPL	2000-04-12
25854	SUPPL	2000-04-12
35381	ORIG	1999-09-21
3379	ORIG	1999-09-21