Application 205013

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CAFFEINE CITRATE	CAFFEINE CITRATE	SOLUTION;INTRAVENOUS	EQ 30MG BASE/3ML (EQ 10MG BASE/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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205013-001	CAFFEINE CITRATE	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS			2015-09-22

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 · 42 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
2026-08-18 06:07:40	2026-07	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-09-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205013-001	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2015-09-22	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205013-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205013-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205013-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205013-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205013-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205013-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205013-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205013-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205013-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205013-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205013-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205013-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205013-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205013-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205013-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205013-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205013-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205013-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205013-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205013-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205013-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205013-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205013-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205013-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205013-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205013-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205013-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205013-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205013-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205013-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205013-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205013-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205013-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205013-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205013-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205013-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205013-001	AP	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Caffeine Citrate	CAFFEINE CITRATE	Eugia US LLC	8ef448ca-5549-4272-a6b4-5c4f57653c4c	2025-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205013 application number: ANDA205013 ndc (product): 55150-187

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55150-187	Caffeine Citrate	Caffeine Citrate	AuroMedics Pharma LLC	ANDA	Current
55150-187	Caffeine Citrate	Caffeine Citrate	AuroMedics Pharma LLC	ANDA	Current
55150-187	Caffeine Citrate	Caffeine Citrate	AuroMedics Pharma LLC	ANDA	Current
55150-187	Caffeine Citrate	Caffeine Citrate	AuroMedics Pharma LLC	ANDA	Current