Application 203510

Type: NDA
Sponsor: PARAGON BIOTECK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	SOLUTION/DROPS;OPHTHALMIC	2.5%	Yes	Yes
002	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	SOLUTION/DROPS;OPHTHALMIC	10%	Yes	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
N203510-001	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21
N203510-002	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N203510-001	AT
N203510-002	AT

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203510-001	8859623	2033-11-14	U-1594		2014-10-17
N203510-002	8859623	2033-11-14	U-1594		2014-10-17

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	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203510-001	PHENYLEPHRINE HYDROCHLORIDE	2.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203510-002	PHENYLEPHRINE HYDROCHLORIDE	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2013-03-21	`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	N203510-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203510-002	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203510-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203510-002	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203510-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203510-002	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203510-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203510-002	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203510-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203510-002	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203510-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203510-002	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203510-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203510-002	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203510-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203510-002	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203510-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203510-002	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203510-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203510-002	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203510-001	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203510-002	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203510-001	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203510-002	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203510-001	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203510-002	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203510-001	AT	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203510-002	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203510-001	AT	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203510-002	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203510-001	AT	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203510-002	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203510-001	AT	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203510-002	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203510-001	AT	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203510-002	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203510-001	AT	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203510-002	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203510-001	AT	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203510-002	AT	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203510-001	8859623	2033-11-14	U-1594	2014-10-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203510-002	8859623	2033-11-14	U-1594	2014-10-17	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Paragon BioTeck, Inc.	a4d3fe20-f063-11e0-ac29-0002a5d5c51b	2023-06-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203510 application number: NDA203510 ndc (product): 42702-102 ndc (product): 42702-103
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Bausch & Lomb Americas Inc.	dcd09e27-93ec-463f-8062-a7dad96c4d0f	2023-03-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203510 application number: NDA203510

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42702-102	Phenylephrine Hydrochloride	phenylephrine hydrochloride	Paragon BioTeck, Inc.	NDA	Current
42702-102	Phenylephrine Hydrochloride	phenylephrine hydrochloride	Paragon BioTeck, Inc.	NDA	Current
42702-102	Phenylephrine Hydrochloride	phenylephrine hydrochloride	Paragon BioTeck, Inc.	NDA	Current
42702-102	Phenylephrine Hydrochloride	phenylephrine hydrochloride	Paragon BioTeck, Inc.	NDA	Current
42702-102	Phenylephrine Hydrochloride	phenylephrine hydrochloride	Paragon BioTeck, Inc.	NDA	Current
42702-102	Phenylephrine Hydrochloride	phenylephrine hydrochloride	Paragon BioTeck, Inc.	NDA	Current
42702-103	Phenylephrine Hydrochloride	phenylephrine hydrochloride	Paragon BioTeck, Inc.	NDA	Current
42702-103	Phenylephrine Hydrochloride	phenylephrine hydrochloride	Paragon BioTeck, Inc.	NDA	Current
42702-103	Phenylephrine Hydrochloride	phenylephrine hydrochloride	Paragon BioTeck, Inc.	NDA	Current
42702-103	Phenylephrine Hydrochloride	phenylephrine hydrochloride	Paragon BioTeck, Inc.	NDA	Current
42702-103	Phenylephrine Hydrochloride	phenylephrine hydrochloride	Paragon BioTeck, Inc.	NDA	Current
42702-103	Phenylephrine Hydrochloride	phenylephrine hydrochloride	Paragon BioTeck, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72851	SUPPL	2022-12-09
72838	SUPPL	2022-12-09
62670	SUPPL	2020-04-24
62597	SUPPL	2020-04-20
24437	ORIG	2013-09-20
22925	ORIG	2013-09-20
19479	ORIG	2013-03-26
32435	ORIG	2013-03-22
64047	ORIG	1900-01-01
51566	ORIG	1900-01-01
51565	ORIG	1900-01-01
51564	ORIG	1900-01-01