Application 065095

Type
ANDA
Sponsor
HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATETABLET;ORALEQ 100MG BASENoYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065095-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065095-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS2003-07-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS2003-07-023f01610625f2…
2019-09-15 20:21 UTC2019-09A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS2003-07-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS2003-07-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065095-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065095-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065095-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065095-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065095-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065095-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065095-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065095-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065095-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065095-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065095-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065095-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065095-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065095-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065095-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065095-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065095-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065095-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065095-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065095-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065095-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065095-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065095-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065095-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065095-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065095-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065095-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065095-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065095-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065095-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065095-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065095-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065095-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065095-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065095-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065095-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065095-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065095-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065095-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065095-001AB1cb3db0bc1861…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.c96d3986-9d92-4ec4-a319-a50aeb2f4fe72026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065095
application number: ANDA065095
ndc (product): 55289-866
Doxycycline HyclateDOXYCYCLINE HYCLATECardinal Health 107, LLCa34fbbc7-09dc-42d6-a075-f4ea8f170ba72026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065095
application number: ANDA065095
ndc (product): 55154-8079
Doxycycline HyclateDOXYCYCLINE HYCLATEAmerican Health Packaging10988250-b267-4f10-b264-5f127cc1ae182026-02-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065095
application number: ANDA065095
ndc (product): 62584-693
DoxycyclineDOXYCYCLINE HYCLATEREMEDYREPACK INC.db53637e-16ac-41b0-b9d5-553471405d642026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065095
application number: ANDA065095
ndc (product): 70518-3039
Doxycycline HyclateDOXYCYCLINE HYCLATENorthwind Health Company, LLCf7f6dc0d-cf8f-50b5-e053-6294a90a9e592026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065095
application number: ANDA065095
Doxycycline HyclateDOXYCYCLINE HYCLATEQPharma, Inc.fbd0a22f-b365-c0a2-e053-6394a90a1e072025-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065095
application number: ANDA065095
DoxycyclineDOXYCYCLINE HYCLATEGolden State Medical Supply, Inc.5fbef611-39db-4a8e-8f46-090c95a270422025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065095
application number: ANDA065095
ndc (product): 60429-069
Doxycycline HyclateDOXYCYCLINE HYCLATEMajor Pharmaceuticalse7c14a8e-c713-4f03-94e8-1ec9ae077d4d2025-10-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065095
application number: ANDA065095
ndc (product): 0904-0430
DoxycyclineDOXYCYCLINE HYCLATECardinal Health 107, LLC53deb73a-c828-46e8-994e-d84e3bf8dc982025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065095
application number: ANDA065095
ndc (product): 55154-7128
Doxycycline HyclateDOXYCYCLINE HYCLATEHikma Pharmaceuticals USA Inc.9b52e0a7-f024-4d8a-a59e-374946e60b442025-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065095
application number: ANDA065095
ndc (product): 0143-2112
Doxycycline HyclateDOXYCYCLINE HYCLATEA-S Medication Solutions6772807d-a39e-47ce-9584-a08e7f8940d22025-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065095
application number: ANDA065095

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 54 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-2112DoxycyclineDoxycycline hyclateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-2112DoxycyclineDoxycycline hyclateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-2112DoxycyclineDoxycycline hyclateWest-Ward Pharmaceuticals CorpANDACurrent
0143-2112DoxycyclineDoxycycline hyclateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-2112DoxycyclineDoxycycline hyclateWest-Ward Pharmaceuticals CorpANDACurrent
0440-7483DoxycyclineDoxycycline hyclateLiberty Pharmaceuticals, Inc.ANDACurrent
0904-0430DoxycyclineDoxycycline hyclateMajor PharmaceuticalsANDACurrent
0904-0430DoxycyclineDoxycycline hyclateMajor PharmaceuticalsANDACurrent
0904-0430DoxycyclineDoxycycline hyclateMajor PharmaceuticalsANDACurrent
0904-0430DoxycyclineDoxycycline hyclateMajor PharmaceuticalsANDACurrent
10544-073DoxycyclineDoxycycline hyclateBlenheim Pharmacal, Inc.ANDACurrent
11819-311Doxycycline HyclateDoxycycline hyclateHHS/Program Support Center/Supply Service CenterANDACurrent
21695-581DoxycyclineDoxycycline HyclateRebel Distributors Corp.ANDACurrent
33261-143DoxycyclineDoxycycline hyclateAidarex Pharmaceuticals LLCANDACurrent
42852-002Doxycycline HyclateDoxycycline HyclateApothecary Shop Wholesale Inc.ANDACurrent
50090-3218DoxycyclineDoxycycline hyclateA-S Medication SolutionsANDACurrent
55154-7128DoxycyclineDoxycycline hyclateCardinal HealthANDACurrent
55154-7128DoxycyclineDoxycycline hyclateCardinal HealthANDACurrent
55154-7128DoxycyclineDoxycycline hyclateCardinal HealthANDACurrent
55154-7128DoxycyclineDoxycycline hyclateCardinal HealthANDACurrent
55154-7128DoxycyclineDoxycycline hyclateCardinal HealthANDACurrent
55154-7469DoxycyclineDoxycycline hyclateCardinal HealthANDACurrent
55154-8079DoxycyclineDoxycycline hyclateCardinal HealthANDACurrent
55154-8079DoxycyclineDoxycycline hyclateCardinal HealthANDACurrent
55154-8079DoxycyclineDoxycycline hyclateCardinal HealthANDACurrent
55289-866DoxycyclineDoxycycline hyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-866DoxycyclineDoxycycline hyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-866DoxycyclineDoxycycline hyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-866DoxycyclineDoxycycline hyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-866DoxycyclineDoxycycline hyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-866DoxycyclineDoxycycline hyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-866DoxycyclineDoxycycline hyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-866DoxycyclineDoxycycline hyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
60429-069DoxycyclineDoxycycline hyclateGolden State Medical Supply, Inc.ANDACurrent
60429-069DoxycyclineDoxycycline hyclateGolden State Medical Supply, Inc.ANDACurrent
60429-069DoxycyclineDoxycycline hyclateGolden State Medical Supply, Inc.ANDACurrent
60429-069DoxycyclineDoxycycline hyclateGolden State Medical Supply, Inc.ANDACurrent
60760-215DoxycyclineDoxycycline hyclateSt Marys Medical Park PharmacyANDACurrent
60760-215DoxycyclineDoxycycline hyclateSt Marys Medical Park PharmacyANDACurrent
60760-215DoxycyclineDoxycycline hyclateSt Marys Medical Park PharmacyANDACurrent
60760-215DoxycyclineDoxycycline hyclateSt Marys Medical Park PharmacyANDACurrent
61919-433DOXYCYCLINEDOXYCYCLINEDirectRXANDACurrent
61919-433DOXYCYCLINEDOXYCYCLINEDirectRXANDACurrent
62584-693DoxycyclineDoxycycline HyclateAmerican Health PackagingANDACurrent
62584-693DoxycyclineDoxycycline HyclateAmerican Health PackagingANDACurrent
62584-693DoxycyclineDoxycycline HyclateAmerican Health PackagingANDACurrent
62584-693DoxycyclineDoxycycline HyclateAmerican Health PackagingANDACurrent
68071-4110DoxycyclineDoxycycline hyclateNuCare Pharmaceuticals,Inc.ANDACurrent
68387-381DoxycyclineDoxycycline hyclateKeltman Pharmaceuticals Inc.ANDACurrent
68645-021DoxycyclineDoxycycline hyclateLegacy Pharmaceutical PackagingANDACurrent
70518-3039DoxycyclineDoxycycline hyclateREMEDYREPACK INC.ANDACurrent
70518-3039DoxycyclineDoxycycline hyclateREMEDYREPACK INC.ANDACurrent
70518-3039DoxycyclineDoxycycline hyclateREMEDYREPACK INC.ANDACurrent
70518-3039DoxycyclineDoxycycline hyclateREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39415SUPPL2014-07-30
30652SUPPL2014-07-24