FDA.reportPublic FDA data

Application 216935

Type
ANDA
Sponsor
LUPIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISOLONE ACETATEPREDNISOLONE ACETATESUSPENSION/DROPS;OPHTHALMIC1%NoNo

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
A216935-001PREDNISOLONE ACETATEPREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216935-001AB

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 UTC2026-02A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-0279d66fd596c7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216935-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216935-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216935-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216935-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216935-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216935-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216935-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216935-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216935-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216935-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216935-001AB179d66fd596c7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216935-001AB1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216935-001CGT2025-04-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A216935-001CGT2025-04-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216935-001CGT2025-04-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216935-001CGT2025-04-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216935-001CGT2025-04-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216935-001CGT2025-04-092680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216935-001CGT2025-04-09d8e5a09893c0…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREDNISOLONE ACETATEPREDNISOLONE ACETATEA-S Medication Solutionsf0e1b691-73ff-49ee-8a3c-71769b284ab82026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216935
application number: ANDA216935
PREDNISOLONE ACETATEPREDNISOLONE ACETATERedpharm Drug3dd0195c-8522-bbf9-e063-6394a90a9f3e2025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216935
application number: ANDA216935
PREDNISOLONE ACETATEPREDNISOLONE ACETATELupin Pharmaceuticals, Inc.75fbeab1-ce8d-4999-a875-472174be5cc62025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216935
application number: ANDA216935

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85558ORIG 2026-03-30