Home Applications 208765 Application 208765
Type ANDA
Sponsor MAYNE PHARMA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET;ORAL EQ 75MG BASE No No 002 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET;ORAL EQ 150MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208765-001 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2017-06-14 A208765-002 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2017-06-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 86 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 A208765-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2017-06-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208765-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2017-06-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208765-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2017-06-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208765-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2017-06-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208765-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2017-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208765-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2017-06-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208765-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2017-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208765-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2017-06-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208765-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2017-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208765-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2017-06-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208765-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2017-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208765-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2017-06-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208765-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2017-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208765-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2017-06-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208765-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2017-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208765-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2017-06-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208765-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2017-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208765-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2017-06-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208765-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2017-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208765-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2017-06-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208765-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2017-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208765-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2017-06-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208765-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2017-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208765-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2017-06-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208765-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2017-06-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208765-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2017-06-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208765-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2017-06-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208765-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2017-06-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208765-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2017-06-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208765-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2017-06-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208765-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2017-06-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208765-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2017-06-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208765-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2017-06-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208765-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2017-06-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208765-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2017-06-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208765-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2017-06-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208765-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2017-06-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208765-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2017-06-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208765-001 DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET / ORAL AB 2017-06-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A208765-002 DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET / ORAL AB 2017-06-14 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 6 of 8 · 145 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Doxycycline Hyclate DOXYCYCLINE HYCLATE Bryant Ranch Prepack 861b71f3-37e8-4596-838c-c8dad8ed5ff4 2025-02-04 Warnings, Adverse reactions Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE Doxycycline Hyclate DOXYCYCLINE HYCLATE Bryant Ranch Prepack 942ab6dd-e355-41da-b139-72cc8b7a2667 2025-02-03 Warnings, Adverse reactions Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE Doxycycline Hyclate DOXYCYCLINE HYCLATE Bryant Ranch Prepack 5b4390ed-a0ec-4ef8-864c-8a33a83653f9 2025-01-31 Warnings, Adverse reactions Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE Doxycycline Hyclate DOXYCYCLINE HYCLATE Redpharm Drug, Inc. 09d19663-a8b9-0c3f-e063-6394a90aa446 2025-01-23 Warnings, Adverse reactions Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE Redpharm Drug 1a3c713f-bc4f-4848-e063-6394a90a0272 2025-01-23 Warnings, Adverse reactions Name fallback brand name: DOXYCYCLINE HYCLATE generic name: DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE Redpharm Drug 0b251a58-30d8-dfec-e063-6294a90a3b45 2025-01-23 Warnings, Adverse reactions Name fallback brand name: DOXYCYCLINE HYCLATE generic name: DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE direct rx b56dffde-1334-f5a0-e053-2a95a90a717c 2025-01-17 Warnings, Adverse reactions Name fallback brand name: DOXYCYCLINE HYCLATE generic name: DOXYCYCLINE HYCLATE Doxycycline hyclate DOXYCYCLINE HYCLATE Proficient Rx LP 65b3a0e2-32a5-436a-b805-854fbffcb611 2025-01-01 Warnings, Adverse reactions Name fallback brand name: Doxycycline hyclate generic name: DOXYCYCLINE HYCLATE Doxycycline Hyclate DOXYCYCLINE HYCLATE Proficient Rx LP 19d93cd3-6ac6-4e5d-8e7e-1a48799df3cf 2025-01-01 Warnings, Adverse reactions Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE Doxycycline Hyclate DOXYCYCLINE HYCLATE Advanced Rx Pharmacy of Tennessee, LLC b4f2ab4f-c32b-6435-e053-2995a90a69b6 2024-12-31 Warnings, Adverse reactions Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE Doxycycline Hyclate DOXYCYCLINE HYCLATE Advanced Rx Pharmacy of Tennessee, LLC ecab47ea-d7b9-515d-e053-2995a90adc46 2024-12-31 Warnings, Adverse reactions Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE Doxycycline Hyclate DOXYCYCLINE HYCLATE Advanced Rx Pharmacy of Tennessee, LLC f5ed9293-15f8-ecfa-e053-2a95a90ab6a4 2024-12-31 Warnings, Adverse reactions Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE Doxycycline Hyclate DOXYCYCLINE HYCLATE Quality Care Products, LLC 2a3b79e8-f14c-4b44-9d3e-3c92a82269bd 2024-12-16 Warnings, Adverse reactions Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE Doxycycline Hyclate DOXYCYCLINE HYCLATE Diirect_rx 1b403f4b-1c61-3991-e063-6394a90ae4f2 2024-12-02 Warnings, Adverse reactions Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE Bryant Ranch Prepack fd58dbe5-aab2-4378-b054-d5c60d87074e 2024-10-08 Warnings, Adverse reactions Name fallback brand name: DOXYCYCLINE HYCLATE generic name: DOXYCYCLINE HYCLATE Doxycycline Hyclate DOXYCYCLINE HYCLATE NCS HealthCare of KY, LLC dba Vangard Labs 104cac0f-7c99-4faf-ba08-0159ed767a3e 2024-10-07 Warnings, Adverse reactions Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE Doxycycline hyclate DOXYCYCLINE HYCLATE Bryant Ranch Prepack 30b041a0-8f5f-4d9f-b11b-106f7432955b 2024-08-23 Warnings, Adverse reactions Name fallback brand name: Doxycycline hyclate generic name: DOXYCYCLINE HYCLATE Doxycycline hyclate DOXYCYCLINE HYCLATE Zydus Lifesciences Limited 68b3aba5-f1e4-4cdf-b244-0302aa8595fe 2024-08-16 Name fallback brand name: Doxycycline hyclate generic name: DOXYCYCLINE HYCLATE Doxycycline hyclate DOXYCYCLINE HYCLATE Zydus Lifesciences Limited fc8213e3-e546-495f-ac2c-3856db79c6e1 2024-08-16 Name fallback brand name: Doxycycline hyclate generic name: DOXYCYCLINE HYCLATE Doxycycline Hyclate DOXYCYCLINE HYCLATE Bryant Ranch Prepack 214e5a5c-7f3e-478b-93d3-1713de9e7672 2024-08-07 Warnings, Adverse reactions Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 51862-695 Doxycycline Hyclate Doxycycline Hyclate Mayne Pharma Inc. ANDA Current 51862-695 Doxycycline Hyclate Doxycycline Hyclate Mayne Pharma Inc. ANDA Current 51862-695 Doxycycline Hyclate Doxycycline Hyclate Mayne Pharma Inc. ANDA Current 51862-696 Doxycycline Hyclate Doxycycline Hyclate Mayne Pharma Inc. ANDA Current 51862-696 Doxycycline Hyclate Doxycycline Hyclate Mayne Pharma Inc. ANDA Current 51862-696 Doxycycline Hyclate Doxycycline Hyclate Mayne Pharma Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 48721 ORIG 2017-06-15