Application 207531

Type
ANDA
Sponsor
EPIC PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZITHROMYCINAZITHROMYCINFOR SUSPENSION;ORALEQ 100MG BASE/5MLNoNo
002AZITHROMYCINAZITHROMYCINFOR SUSPENSION;ORALEQ 200MG BASE/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A207531-001AZITHROMYCINAZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09
A207531-002AZITHROMYCINAZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207531-001AB
A207531-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09caaa826d4ba7…
2026-08-18 06:07:402026-07A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A207531-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207531-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207531-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207531-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207531-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207531-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207531-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207531-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207531-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207531-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207531-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207531-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207531-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207531-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207531-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207531-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207531-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207531-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207531-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207531-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207531-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207531-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207531-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207531-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207531-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207531-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207531-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207531-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207531-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207531-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207531-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207531-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207531-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207531-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207531-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207531-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207531-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207531-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207531-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207531-002AB1bb7c543d1eb4…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AZITHROMYCINAZITHROMYCINA-S Medication Solutions76093152-e2d7-4fe1-8568-1f0fec1747c22026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531
AZITHROMYCINAZITHROMYCINPreferred Pharmaceuticals, Inc.9e4fbd52-43e4-4d87-a136-f4d680a8d0c12026-03-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531
ndc (product): 68788-7549
AZITHROMYCINAZITHROMYCINA-S Medication Solutions405ab07f-7d1d-4552-ad3b-2a03be8e99492026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531
ndc (product): 50090-6296
AZITHROMYCINAZITHROMYCINEpic Pharma, LLC59c4b783-4ff7-4269-969b-58a10e12b12b2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531
ndc (product): 42806-147
ndc (product): 42806-150
ndc (product): 42806-149
ndc (product): 42806-151
AZITHROMYCINAZITHROMYCINPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS714f6f55-278a-4fcf-8d4e-2ad9b43623a32025-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531
ndc (product): 24658-706
ndc (product): 24658-708
AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals, Inc.3f7c7421-411d-c04e-e063-6394a90a4aa02025-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531
AZITHROMYCINAZITHROMYCINDirectRxd564d91e-3039-c120-e053-2995a90ae6db2025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531
ndc (product): 72189-314
AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.90a506cd-aae7-a622-e053-2a95a90ad3522024-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531
ndc (product): 68071-5035
AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.82454fb2-e524-ecb8-e053-2991aa0a6e7c2024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531
ndc (product): 68071-4773
AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.8389c336-25eb-a96f-e053-2a91aa0a0dd82024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531
ndc (product): 68071-4795
AZITHROMYCINAZITHROMYCINProficient Rx LPe1172805-0930-4fb9-8a2f-e0d6a04306302022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531
ndc (product): 71205-566
AZITHROMYCINAZITHROMYCINProficient Rx LPb3761d39-9b79-4908-8b05-a1c91e5999982022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531
ndc (product): 71205-253

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 49 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24658-706AZITHROMYCINAZITHROMYCINPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALSANDACurrent
24658-706AZITHROMYCINAZITHROMYCINPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALSANDACurrent
24658-708AZITHROMYCINAZITHROMYCINPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALSANDACurrent
24658-708AZITHROMYCINAZITHROMYCINPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALSANDACurrent
42806-147AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-147AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-147AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-147AZITHROMYCINazithromycinEpic Pharma, LLCANDACurrent
42806-149AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-149AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-149AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-149AZITHROMYCINazithromycinEpic Pharma, LLCANDACurrent
42806-150AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-150AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-150AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-150AZITHROMYCINazithromycinEpic Pharma, LLCANDACurrent
42806-151AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-151AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-151AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-151AZITHROMYCINazithromycinEpic Pharma, LLCANDACurrent
50090-6296AZITHROMYCINazithromycinA-S Medication SolutionsANDACurrent
53002-2231AZITHROMYCINAZITHROMYCINRPK Pharmaceuticals, Inc.ANDACurrent
55700-731AZITHROMYCINAZITHROMYCINQuality Care Products LLCANDACurrent
55700-731AZITHROMYCINAZITHROMYCINQuality Care Products LLCANDACurrent
55700-731AZITHROMYCINAZITHROMYCINQuality Care Products LLCANDACurrent
55700-784AZITHROMYCINAZITHROMYCINQuality Care Products, LLCANDACurrent
55700-784AZITHROMYCINAZITHROMYCINQuality Care Products, LLCANDACurrent
68071-4773AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4773AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4773AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4773AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4795AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4795AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5035AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5035AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7549AZITHROMYCINAZITHROMYCINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7549AZITHROMYCINAZITHROMYCINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7549AZITHROMYCINAZITHROMYCINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7549AZITHROMYCINAZITHROMYCINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7636AZITHROMYCINAZITHROMYCINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7636AZITHROMYCINAZITHROMYCINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7636AZITHROMYCINAZITHROMYCINPreferred Pharmaceuticals Inc.ANDACurrent
71205-253AZITHROMYCINAZITHROMYCINProficient Rx LPANDACurrent
71205-253AZITHROMYCINAZITHROMYCINProficient Rx LPANDACurrent
71205-253AZITHROMYCINAZITHROMYCINProficient Rx LPANDACurrent
71205-253AZITHROMYCINAZITHROMYCINProficient Rx LPANDACurrent
71205-566AZITHROMYCINAZITHROMYCINProficient Rx LPANDACurrent
71205-566AZITHROMYCINAZITHROMYCINProficient Rx LPANDACurrent
72189-314AZITHROMYCINAZITHROMYCINDirectRxANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48647ORIG2017-06-06