FDA.reportPublic FDA data

Application 216830

Type
NDA
Sponsor
DR REDDYS LABS SA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS20MG/250ML (0.08MG/ML)YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N216830-001PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEPHENYLEPHRINE HYDROCHLORIDE20MG/250ML (0.08MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-05-30

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N216830-001125645612044-08-08Drug product2026-03-27

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N216830-001PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/250ML (0.08MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-05-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216830-001PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/250ML (0.08MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-05-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N216830-001PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/250ML (0.08MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-05-306a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216830-001PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE20MG/250ML (0.08MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-05-30a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216830-001125645612044-08-08Drug product2026-03-27a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
phenylephrine hydrochloride injection, solutionPHENYLEPHRINE HYDROCHLORIDE INJECTION, SOLUTIONDr. Reddy's Laboratories Inc.71b8fb8a-e13a-246f-f7b4-aa912b9ccd542026-03-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 216830
application number: NDA216830

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85107ORIG 2026-02-23
82425ORIG 2025-06-02
82426ORIG 2025-05-30