Application 060751

Type
ANDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEO-CORTEFHYDROCORTISONE ACETATE; NEOMYCIN SULFATEOINTMENT;TOPICAL0.5%;EQ 3.5MG BASE/GMNoNo
002NEO-CORTEFHYDROCORTISONE ACETATE; NEOMYCIN SULFATEOINTMENT;TOPICAL1%;EQ 3.5MG BASE/GMNoNo
003NEO-CORTEFHYDROCORTISONE ACETATE; NEOMYCIN SULFATEOINTMENT;TOPICAL2.5%;EQ 3.5MG BASE/GMNoNo

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
A060751-001NEO-CORTEFHYDROCORTISONE ACETATE; NEOMYCIN SULFATE0.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 1982
A060751-002NEO-CORTEFHYDROCORTISONE ACETATE; NEOMYCIN SULFATE1%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 1982
A060751-003NEO-CORTEFHYDROCORTISONE ACETATE; NEOMYCIN SULFATE2.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 1982

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 UTC2026-02A060751-001NEO-CORTEF0.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A060751-002NEO-CORTEF1%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A060751-003NEO-CORTEF2.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A060751-001NEO-CORTEF0.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A060751-002NEO-CORTEF1%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A060751-003NEO-CORTEF2.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A060751-001NEO-CORTEF0.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A060751-002NEO-CORTEF1%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A060751-003NEO-CORTEF2.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A060751-001NEO-CORTEF0.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A060751-002NEO-CORTEF1%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A060751-003NEO-CORTEF2.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A060751-001NEO-CORTEF0.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A060751-002NEO-CORTEF1%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A060751-003NEO-CORTEF2.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A060751-001NEO-CORTEF0.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A060751-002NEO-CORTEF1%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A060751-003NEO-CORTEF2.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A060751-001NEO-CORTEF0.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A060751-002NEO-CORTEF1%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A060751-003NEO-CORTEF2.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A060751-001NEO-CORTEF0.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A060751-002NEO-CORTEF1%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A060751-003NEO-CORTEF2.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A060751-001NEO-CORTEF0.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A060751-002NEO-CORTEF1%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A060751-003NEO-CORTEF2.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A060751-001NEO-CORTEF0.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A060751-002NEO-CORTEF1%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A060751-003NEO-CORTEF2.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A060751-001NEO-CORTEF0.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A060751-002NEO-CORTEF1%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A060751-003NEO-CORTEF2.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A060751-001NEO-CORTEF0.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A060751-002NEO-CORTEF1%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A060751-003NEO-CORTEF2.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A060751-001NEO-CORTEF0.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A060751-002NEO-CORTEF1%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A060751-003NEO-CORTEF2.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A060751-001NEO-CORTEF0.5%;EQ 3.5MG BASE/GMOINTMENT / TOPICALApproved before 19828072bd15b7f6…