Application 062031

Type
ANDA
Sponsor
ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATECAPSULE;ORALEQ 100MG BASENoNo
002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATECAPSULE;ORALEQ 50MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062031-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 1982
A062031-002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A062031-001AB
A062031-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-13782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A062031-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062031-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062031-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062031-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062031-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062031-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062031-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062031-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062031-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062031-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062031-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062031-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062031-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062031-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062031-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062031-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062031-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062031-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062031-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062031-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062031-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062031-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062031-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062031-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062031-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062031-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062031-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062031-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062031-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062031-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062031-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062031-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062031-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062031-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062031-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062031-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062031-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062031-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062031-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A062031-002AB1782e0a99824c…

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 8 · 148 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINE HYCLATEREMEDYREPACK INC.2c29f716-bdb0-437d-92a4-d856b87db9762026-08-06Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.2305ab4a-7d08-41f6-9c39-c9b6835be3892026-08-05Warnings, Adverse reactionsName fallback
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.c8194d6e-c407-465e-a342-4d2d9756dfc42026-08-04Warnings, Adverse reactionsName fallback
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE
DoxycyclineDOXYCYCLINE HYCLATEREMEDYREPACK INC.db53637e-16ac-41b0-b9d5-553471405d642026-08-03Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.cf95b2ca-2cf8-49a8-8e3a-f9b0f5b2072c2026-07-29Warnings, Adverse reactionsName fallback
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.3af9348c-a98b-4059-a5ef-4229e2b33af02026-07-20Warnings, Adverse reactionsName fallback
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.0994d23a-f9e4-4c33-ba44-a1f4ae4a312c2026-07-20Warnings, Adverse reactionsName fallback
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.1401d590-0967-4c6b-b52b-a83e9f6df0972026-07-17Warnings, Adverse reactionsName fallback
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.b988f851-cc06-4570-9706-cf65d370bd8e2026-07-17Warnings, Adverse reactionsName fallback
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.35aa295e-ff1b-453b-8eeb-65bbeda3baa52026-07-17Warnings, Adverse reactionsName fallback
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE
doxycycline hyclateDOXYCYCLINE HYCLATEHAWAII REPACK, INC88c429a1-351d-432e-b69b-d7a0afca482a2026-07-09Warnings, Adverse reactionsName fallback
brand name: doxycycline hyclate
generic name: DOXYCYCLINE HYCLATE
Doxycyclate HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.4dc319c1-b7ef-40e4-9e66-fb24cfdefea82026-07-09Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.6e3d0691-c071-441c-9b00-22a3803050662026-07-03Warnings, Adverse reactionsName fallback
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEChartwell RX, LLCfad03768-f1d2-459f-965e-0ec29f189f1f2026-06-30Warnings, Adverse reactionsName fallback
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEStrides Pharma Science Limited2deeee4f-b342-a178-e063-6394a90af8972026-06-26Warnings, Adverse reactionsName fallback
brand name: DOXYCYCLINE HYCLATE
generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEStrides Pharma Science Limitedb8b76aaa-575b-497f-b854-c42bc992c7842026-06-26Warnings, Adverse reactionsName fallback
brand name: DOXYCYCLINE HYCLATE
generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATESt. Mary's Medical Park Pharmacy02f87c60-8425-1a1e-e063-6294a90a0c942026-06-25Warnings, Adverse reactionsName fallback
brand name: DOXYCYCLINE HYCLATE
generic name: DOXYCYCLINE HYCLATE
doxycycline hyclateDOXYCYCLINE HYCLATESlate Run Pharmaceuticals, LLCf31e69fc-e513-40e4-91b5-22ccf1ed94372026-06-23Warnings, Adverse reactionsName fallback
brand name: doxycycline hyclate
generic name: DOXYCYCLINE HYCLATE
DoxycyclineDOXYCYCLINE HYCLATEAcella Pharmaceuticals, LLC3fb9f5ad-90a2-4858-bc34-f800d8b2fa902026-06-19Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEUnit Dose Solutions, Inc.548d4218-2feb-8716-e063-6394a90afbe32026-06-18Warnings, Adverse reactionsName fallback
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-5440Doxycycline HyclateDoxycycline HyclateActavis Pharma, Inc.ANDACurrent
0591-5440Doxycycline HyclateDoxycycline HyclateActavis Pharma, Inc.ANDACurrent
0591-5440Doxycycline HyclateDoxycycline HyclateActavis Pharma, Inc.ANDACurrent
0591-5535Doxycycline HyclateDoxycycline HyclateActavis Pharma, Inc.ANDACurrent
0591-5535Doxycycline HyclateDoxycycline HyclateActavis Pharma, Inc.ANDACurrent
0591-5535Doxycycline HyclateDoxycycline HyclateActavis Pharma, Inc.ANDACurrent
33261-899Doxycycline HyclateDoxycycline HyclateAidarex Pharmaceuticals LLCANDACurrent
51655-184Doxycycline HyclateDoxycycline HyclateNorthwind PharmaceuticalsANDACurrent
53808-0962Doxycycline HyclateDoxycycline HyclateState of Florida DOH Central PharmacyANDACurrent
55154-2650Doxycycline HyclateDoxycycline HyclateCardinal HealthANDACurrent
60687-118Doxycycline HyclateDoxycycline HyclateAmerican Health PackagingANDACurrent
60687-118Doxycycline HyclateDoxycycline HyclateAmerican Health PackagingANDACurrent
60687-118Doxycycline HyclateDoxycycline HyclateAmerican Health PackagingANDACurrent
64725-5440Doxycycline HyclateDoxycycline HyclateTYA PharmaceuticalsANDACurrent
71335-0635Doxycycline HyclateDoxycycline HyclateBryant Ranch PrepackANDACurrent