Application 208250

Type
ANDA
Sponsor
CSPC OUYI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZITHROMYCINAZITHROMYCINTABLET;ORALEQ 250MG BASENoNo

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
A208250-001AZITHROMYCINAZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208250-001AB

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 UTC2026-02A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-173f01610625f2…
2019-09-15 20:21 UTC2019-09A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17cb3db0bc1861…

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 UTC2026-02A208250-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208250-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208250-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208250-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208250-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208250-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208250-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208250-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208250-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208250-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208250-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208250-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208250-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208250-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208250-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208250-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208250-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208250-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208250-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208250-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208250-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A208250-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208250-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208250-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208250-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A208250-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208250-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208250-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208250-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208250-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208250-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208250-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208250-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208250-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208250-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208250-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208250-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208250-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208250-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208250-001AB1cb3db0bc1861…

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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPD-Rx Pharmaceuticals, Inc.7ab854bf-eb04-42c4-a403-096b60581bb42026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPrecision Dose, Inc.d9b66736-3f1a-4d6d-bdc4-274f5adfb40c2026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
AZITHROMYCINAZITHROMYCINDIRECT RXa5b4092d-ab72-f5d1-e053-2995a90ac5822026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
ndc (product): 72189-089
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEREMEDYREPACK INC.f0cfda1a-910f-4764-8658-263037df5ea82026-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPreferred Pharmaceuticals Inc.b3c84aea-7ba7-4aae-999c-db740a9e53df2026-01-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEAvPAKb635019e-7fd4-7f9e-e053-2a95a90a388c2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
ndc (product): 50268-074
Azithromycin DihydrateAZITHROMYCIN DIHYDRATERedpharm Drug44f52ce0-ad3f-7d80-e063-6294a90ad0862025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEA-S Medication Solutionsdf9b39b7-d42d-4c4b-b492-9fd228978dec2025-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
ndc (product): 50090-4601
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPD-Rx Pharmaceuticals, Inc.e9800bbe-e8bf-4689-a8a5-dc23b5d2ee562025-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
ndc (product): 72789-081
Azithromycin DihydrateAZITHROMYCIN DIHYDRATETAGI Pharma, Inc.9f0501bf-d1c4-46a5-b253-3b9e61015e822025-03-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
ndc (product): 51224-022
Azithromycin DihydrateAZITHROMYCIN DIHYDRATECoupler LLC2cc99fae-a72c-8893-e063-6394a90aa3ef2025-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEProficient Rx LPa8e106cb-7245-45a5-9aad-bd624b1e011d2025-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEAdvanced Rx Pharmacy of Tennessee, LLCf1752913-85ac-01fa-e053-2995a90a2bd82024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
ndc (product): 80425-0218
Azithromycin DihydrateAZITHROMYCIN DIHYDRATENuCare Pharmaceuticals Inc.258dd3c5-dce9-7483-e063-6294a90a40432024-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEQuality Care Products, LLC2065c4ba-e3f5-41a2-b3d5-205dab6469242024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEA-S Medication Solutions1c84a68b-3eaa-4dab-b5e5-e195c7652e672024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
ndc (product): 50090-4527
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEProficient Rx LP8037c6f4-4881-4740-8229-2aee56141cd02022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
ndc (product): 71205-430
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEAsclemed USA, Inc.b08bd8fc-20da-4623-9211-ae669452b16d2020-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
ndc (product): 76420-046

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4527Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4527Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4527Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4601Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4601Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4601Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4601Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4602Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4602Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50268-074Azithromycin DihydrateAzithromycin DihydrateAvPAKANDACurrent
50268-074Azithromycin DihydrateAzithromycin DihydrateAvPAKANDACurrent
50268-074Azithromycin DihydrateAzithromycin DihydrateAvPAKANDACurrent
51224-022Azithromycin DihydrateAzithromycin DihydrateTAGI Pharma, Inc.ANDACurrent
51224-022Azithromycin DihydrateAzithromycin DihydrateTAGI Pharma, Inc.ANDACurrent
53002-3224Azithromycin DihydrateAzithromycin DihydrateRPK Pharmaceuticals, Inc.ANDACurrent
53002-4228Azithromycin DihydrateAzithromycin DihydrateRPK Pharmaceuticals, Inc.ANDACurrent
55700-859Azithromycin DihydrateAzithromycin DihydrateQuality Care Products, LLCANDACurrent
68071-2878Azithromycin DihydrateAzithromycin DihydrateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8101Azithromycin DihydrateAzithromycin DihydratePreferred Pharmaceuticals Inc.ANDACurrent
68788-8101Azithromycin DihydrateAzithromycin DihydratePreferred Pharmaceuticals Inc.ANDACurrent
70518-3501Azithromycin DihydrateAzithromycin DihydrateREMEDYREPACK INC.ANDACurrent
71205-430Azithromycin DihydrateAzithromycin DihydrateProficient Rx LPANDACurrent
71205-430Azithromycin DihydrateAzithromycin DihydrateProficient Rx LPANDACurrent
71205-430Azithromycin DihydrateAzithromycin DihydrateProficient Rx LPANDACurrent
72189-089AZITHROMYCIN DIHYDRATEAZITHROMYCIN DIHYDRATEDIRECT RXANDACurrent
72189-089AZITHROMYCIN DIHYDRATEAZITHROMYCIN DIHYDRATEDIRECT RXANDACurrent
72789-081Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-081Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-081Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-081Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-081Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-170Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-170Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
76420-046Azithromycin DihydrateAzithromycin DihydrateAsclemed USA, Inc.ANDACurrent
80425-0218Azithromycin DihydrateAzithromycin DihydrateAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent