Home Applications 210333 Application 210333
Type ANDA
Sponsor MEITHEAL 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 44 .
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 A210333-001 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 A210333-002 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2 of 3 · 88 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 2019-12-13 00:20 UTC 2019-12 A210333-001 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210333-002 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210333-001 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210333-002 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210333-001 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A210333-002 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210333-001 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210333-002 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210333-001 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A210333-002 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210333-001 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A210333-002 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210333-001 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A210333-002 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210333-001 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A210333-002 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210333-001 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A210333-002 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210333-001 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2018-04-27 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A210333-002 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2018-04-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210333-001 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210333-002 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210333-001 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A210333-002 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210333-001 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A210333-002 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210333-001 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210333-002 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210333-001 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210333-002 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210333-001 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210333-002 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210333-001 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210333-002 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210333-001 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A210333-002 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210333-001 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A210333-002 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210333-001 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210333-002 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2018-04-27 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 69097-535 Phenylephrine hydrochloride Phenylephrine hydrochloride Cipla USA Inc. ANDA Current 69097-614 Phenylephrine hydrochloride Phenylephrine hydrochloride Cipla USA Inc. ANDA Current 71288-808 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE Meitheal Pharmaceuticals Inc. ANDA Current 71288-808 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE Meitheal Pharmaceuticals Inc. ANDA Current 71288-808 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE Meitheal Pharmaceuticals Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 54155 ORIG 2018-05-11