Application 208905

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS10MG/ML (10MG/ML)NoNo
002PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS50MG/5ML (10MG/ML)NoNo
003PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS100MG/10ML (10MG/ML)NoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208905-001PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP1RS2019-01-31
A208905-002PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP1RS2019-01-31
A208905-003PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP1RS2019-01-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A208905-001AP1
A208905-002AP1
A208905-003AP1

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP1RS2019-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP1RS2019-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP1RS2019-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP1RS2019-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP1RS2019-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP1RS2019-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-318072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208905-001AP11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208905-002AP11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208905-003AP11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208905-001AP1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208905-002AP1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208905-003AP1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208905-001AP116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208905-002AP116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208905-003AP116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208905-001AP11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208905-002AP11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208905-003AP11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208905-001AP11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208905-002AP11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208905-003AP11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208905-001AP1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208905-002AP1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208905-003AP1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208905-001AP112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208905-002AP112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208905-003AP112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208905-001AP115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208905-002AP115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208905-003AP115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208905-001AP11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208905-002AP11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208905-003AP11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208905-001AP11d06236e962d9…
2024-10-29 15:01 UTC2024-10A208905-002AP11d06236e962d9…
2024-10-29 15:01 UTC2024-10A208905-003AP11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208905-001AP1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208905-002AP1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208905-003AP1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208905-001AP11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208905-002AP11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208905-003AP11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208905-001AP111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208905-002AP111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208905-003AP111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208905-001AP118072bd15b7f6…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDESandoz Inc5788f8c6-f868-4b83-81dc-dc485d8716c02022-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208905
application number: ANDA208905
ndc (product): 0781-9226
ndc (product): 0781-9227
ndc (product): 0781-9228
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDESandoz Inc6feb2da2-05ef-47bb-9d8d-01b81ad690592022-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208905
application number: ANDA208905
ndc (product): 0781-3422
ndc (product): 0781-3458
ndc (product): 0781-3466

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3422Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3422Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3422Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3422Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3422Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3422Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3422Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3422Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3458Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3458Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3458Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3458Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3458Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3458Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3466Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3466Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3466Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3466Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3466Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-3466Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-9226Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-9226Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-9226Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-9227Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-9227Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-9227Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-9228Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-9228Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent
0781-9228Phenylephrine HydrochloridePhenylephrine HydrochlorideSandoz IncANDACurrent