Home Applications 065277 Application 065277
Type ANDA
Sponsor LANNETT CO INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET;ORAL EQ 20MG BASE No Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065277-001 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065277-001 AB
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065277-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB RS 2005-11-10 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0527-1336 Doxycycline Hyclate Doxycycline Hyclate Lannett Company, Inc. ANDA Current 0527-1336 Doxycycline Hyclate Doxycycline Hyclate Lannett Company, Inc. ANDA Current 0527-1336 Doxycycline Hyclate Doxycycline Hyclate Lannett Company, Inc. ANDA Current 0527-1336 Doxycycline Hyclate Doxycycline Hyclate Lannett Company, Inc. ANDA Current 33261-888 Doxycycline Hyclate Doxycycline Hyclate Aidarex Pharmaceuticals LLC ANDA Current 54799-533 Alodox Doxycyline Hyclate OCuSOFT INC. ANDA Current