Home Applications 212909 Application 212909
Type NDA
Sponsor ETON PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BIORPHEN PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 0.1MG/ML (0.1MG/ML) Yes Yes 002 BIORPHEN PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/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 N212909-001 BIORPHEN PHENYLEPHRINE HYDROCHLORIDE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-10-21 N212909-002 BIORPHEN PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N212909-001 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 2 · 75 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 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N212909-001 BIORPHEN 0.1MG/ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 782e0a99824c…
Observed Orange Book normalized TE history# 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.
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 43598-172 Biorphen Phenylephrine hydrochloride Dr. Reddy's Laboratories Inc. NDA Current 43598-199 Biorphen Phenylephrine hydrochloride Dr. Reddy's Laboratories Inc. NDA Current 71863-202 Biorphen Phenylephrine hydrochloride Eton Pharmaceuticals, Inc. NDA Current 71863-202 Biorphen Phenylephrine hydrochloride Eton Pharmaceuticals, Inc. NDA Current 71863-202 Biorphen Phenylephrine hydrochloride Eton Pharmaceuticals, Inc. NDA Current 71863-202 Biorphen Phenylephrine hydrochloride Eton Pharmaceuticals, Inc. NDA Current 71863-202 Biorphen Phenylephrine hydrochloride Eton Pharmaceuticals, Inc. NDA Current 71863-202 Biorphen Phenylephrine hydrochloride Eton Pharmaceuticals, Inc. NDA Current 71863-202 Biorphen Phenylephrine hydrochloride Eton Pharmaceuticals, Inc. NDA Current 71863-202 Biorphen Phenylephrine hydrochloride Eton Pharmaceuticals, Inc. NDA Current 71863-203 Biorphen Phenylephrine hydrochloride Eton Pharmaceuticals, Inc. NDA Current 71863-208 Biorphen Phenylephrine hydrochloride Eton Pharmaceuticals, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 80510 SUPPL 2024-12-05 80500 SUPPL 2024-12-04 66755 SUPPL 2021-03-12 66752 SUPPL 2021-03-12 62357 ORIG 2020-03-30 60633 ORIG 2019-10-23 60626 ORIG 2019-10-22