Application 211078

Type: ANDA
Sponsor: AMNEAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	50MG/5ML (10MG/ML)	No	No
002	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	100MG/10ML (10MG/ML)	No	No

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
A211078-001	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1		2018-07-19
A211078-002	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1		2018-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211078-001	AP1
A211078-002	AP1

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211078-001	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211078-002	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211078-001	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211078-002	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211078-001	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211078-002	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211078-001	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211078-002	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211078-001	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211078-002	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211078-001	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211078-002	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211078-001	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211078-002	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211078-001	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211078-002	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211078-001	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211078-002	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211078-001	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211078-002	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211078-001	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211078-002	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211078-001	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211078-002	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211078-001	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211078-002	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211078-001	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211078-002	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211078-001	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211078-002	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211078-001	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211078-002	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211078-001	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211078-002	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211078-001	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211078-002	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211078-001	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211078-002	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211078-001	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211078-002	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	2018-07-19	`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	A211078-001	AP1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211078-002	AP1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211078-001	AP1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211078-002	AP1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211078-001	AP1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211078-002	AP1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211078-001	AP1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211078-002	AP1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211078-001	AP1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211078-002	AP1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211078-001	AP1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211078-002	AP1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211078-001	AP1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211078-002	AP1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211078-001	AP1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211078-002	AP1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211078-001	AP1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211078-002	AP1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211078-001	AP1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211078-002	AP1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211078-001	AP1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211078-002	AP1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211078-001	AP1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211078-002	AP1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211078-001	AP1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211078-002	AP1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211078-001	AP1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211078-002	AP1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211078-001	AP1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211078-002	AP1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211078-001	AP1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211078-002	AP1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211078-001	AP1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211078-002	AP1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211078-001	AP1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211078-002	AP1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211078-001	AP1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211078-002	AP1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211078-001	AP1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211078-002	AP1	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenylephrine hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	a05a70b9-f506-456f-a7aa-d9f9c80a7f12	2023-11-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211078 application number: ANDA211078 ndc (product): 70121-1579 ndc (product): 70121-1578

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70121-1578	Phenylephrine hydrochloride	Phenylephrine hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1578	Phenylephrine hydrochloride	Phenylephrine hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1578	Phenylephrine hydrochloride	Phenylephrine hydrochloride	Amneal Biosciences LLC	ANDA	Current
70121-1578	Phenylephrine hydrochloride	Phenylephrine hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1579	Phenylephrine hydrochloride	Phenylephrine hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1579	Phenylephrine hydrochloride	Phenylephrine hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1579	Phenylephrine hydrochloride	Phenylephrine hydrochloride	Amneal Biosciences LLC	ANDA	Current
70121-1579	Phenylephrine hydrochloride	Phenylephrine hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current