Home Applications 021778 Application 021778
Type NDA
Sponsor ENDO PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MEGACE ES MEGESTROL ACETATE SUSPENSION;ORAL 125MG/ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021778-001 MEGACE ES MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL RLD 2005-07-05
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 2 · 43 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 2026-09-14 22:38:34 2026-08 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL RLD 2005-07-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL RLD 2005-07-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL RLD 2005-07-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL RLD 2005-07-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL RLD 2005-07-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL RLD 2005-07-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021778-001 MEGACE ES 125MG/ML SUSPENSION / ORAL AB RLD, RS 2005-07-05 f41ea6bd6efb…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 5 · 181 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021778-001 7101576 2024-04-22 U-755 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021778-001 9040088 2024-04-22 U-755 2015-06-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021778-001 9101540 2024-04-22 U-755 Drug product 2015-08-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021778-001 9101549 2024-04-22 U-755 2015-08-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021778-001 9107827 2024-04-22 U-755 2015-08-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021778-001 7101576 2024-04-22 U-755 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021778-001 9040088 2024-04-22 U-755 2015-06-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021778-001 9101540 2024-04-22 U-755 Drug product 2015-08-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021778-001 9101549 2024-04-22 U-755 2015-08-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021778-001 9107827 2024-04-22 U-755 2015-08-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021778-001 7101576 2024-04-22 U-755 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021778-001 9040088 2024-04-22 U-755 2015-06-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021778-001 9101540 2024-04-22 U-755 Drug product 2015-08-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021778-001 9101549 2024-04-22 U-755 2015-08-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021778-001 9107827 2024-04-22 U-755 2015-08-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021778-001 7101576 2024-04-22 U-755 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021778-001 9040088 2024-04-22 U-755 2015-06-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021778-001 9101540 2024-04-22 U-755 Drug product 2015-08-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021778-001 9101549 2024-04-22 U-755 2015-08-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021778-001 9107827 2024-04-22 U-755 2015-08-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021778-001 7101576 2024-04-22 U-755 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021778-001 9040088 2024-04-22 U-755 2015-06-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021778-001 9101540 2024-04-22 U-755 Drug product 2015-08-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021778-001 9101549 2024-04-22 U-755 2015-08-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021778-001 9107827 2024-04-22 U-755 2015-08-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021778-001 7101576 2024-04-22 U-755 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021778-001 9040088 2024-04-22 U-755 2015-06-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021778-001 9101540 2024-04-22 U-755 Drug product 2015-08-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021778-001 9101549 2024-04-22 U-755 2015-08-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021778-001 9107827 2024-04-22 U-755 2015-08-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021778-001 7101576 2024-04-22 U-755 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021778-001 9040088 2024-04-22 U-755 2015-06-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021778-001 9101540 2024-04-22 U-755 Drug product 2015-08-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021778-001 9101549 2024-04-22 U-755 2015-08-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021778-001 9107827 2024-04-22 U-755 2015-08-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021778-001 7101576 2024-04-22 U-755 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021778-001 9040088 2024-04-22 U-755 2015-06-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021778-001 9101540 2024-04-22 U-755 Drug product 2015-08-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021778-001 9101549 2024-04-22 U-755 2015-08-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021778-001 9107827 2024-04-22 U-755 2015-08-27 1e350fbaab3a…
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 2 of 2 · 21 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 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 17856-0949 Megace ES megesterol acetate Atlantic Biologicals Corps NDA Current 49884-230 Megestrol Acetate Megestrol Acetate Par Pharmaceutical, Inc. NDA AUTHORIZED GENERIC Current 49884-230 Megestrol Acetate Megestrol Acetate Par Pharmaceutical, Inc. NDA AUTHORIZED GENERIC Current 49884-230 Megestrol Acetate Megestrol Acetate Par Pharmaceutical, Inc. NDA AUTHORIZED GENERIC Current 49884-949 Megace ES megesterol acetate Par Pharmaceutical, Inc NDA Current 63481-160 Megace ES megesterol acetate Endo Pharmaceuticals Inc. NDA Current 63481-160 Megace ES megesterol acetate Endo Pharmaceuticals, Inc. NDA Current 63481-160 Megace ES megesterol acetate Endo Pharmaceuticals, Inc. NDA Current 63629-2221 Megestrol Acetate Megestrol Acetate Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 63629-2221 Megestrol Acetate Megestrol Acetate Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current