Application 077309

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACYCLOVIRACYCLOVIRTABLET;ORAL400MGNoNo
002ACYCLOVIRACYCLOVIRTABLET;ORAL800MGNoNo

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
A077309-001ACYCLOVIRACYCLOVIR400MGTABLET / ORALAB2005-09-29
A077309-002ACYCLOVIRACYCLOVIR800MGTABLET / ORALAB2005-09-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077309-001AB
A077309-002AB

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 UTC2026-02A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29782e0a99824c…
2021-12-28 21:50 UTC2021-12A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29782e0a99824c…

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 UTC2026-02A077309-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077309-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077309-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077309-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077309-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077309-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077309-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077309-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077309-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077309-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077309-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077309-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077309-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077309-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077309-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077309-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077309-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077309-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077309-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077309-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077309-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077309-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077309-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077309-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077309-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077309-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077309-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077309-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077309-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077309-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077309-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077309-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077309-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077309-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077309-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077309-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077309-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077309-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077309-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077309-002AB1782e0a99824c…

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 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
acyclovirACYCLOVIRREMEDYREPACK INC.499c6a98-0614-4ded-8526-909942bae8a42026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
ndc (product): 70518-0427
acyclovirACYCLOVIRBryant Ranch Prepackdb35fce0-d7a3-4589-ba60-d78cdb1119cb2026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
ndc (product): 71335-1381
acyclovirACYCLOVIRApotex Corp.7fdeb609-24c4-5024-52c3-6a32bc7f3fcc2025-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
ndc (product): 60505-5307
ndc (product): 60505-5306
acyclovirACYCLOVIRBryant Ranch Prepacka7fd298b-3914-4316-8484-2d3ae188221a2024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
acyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.ada4004a-c10a-6190-e053-2a95a90a5e672024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
ndc (product): 68071-2247
acyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.b2ae0432-bd2a-1480-e053-2a95a90a6fc82024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
ndc (product): 68071-2287
acyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.968800dc-9456-a45f-e053-2995a90aa15e2024-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
ndc (product): 68071-5100
acyclovirACYCLOVIRBryant Ranch Prepackbf1b4142-c5f3-4147-8224-bf63445666942024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
ndc (product): 63629-9174
acyclovirACYCLOVIRProficient Rx LP4c5a75fa-73db-4f48-895f-de1635d33f492021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
ndc (product): 63187-192
acyclovirACYCLOVIRAsclemed USA, Inc.e186fdc9-b60e-4280-8d60-36cae9f2838f2020-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
acyclovirACYCLOVIRProficient Rx LP51052f0e-1a07-405a-a962-981ce9439e022020-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
ndc (product): 71205-391

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 81 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-7033acycloviracyclovirLiberty Pharmaceuticals, Inc.ANDACurrent
0904-5790acycloviracyclovirMajor PharmaceuticalsANDACurrent
0904-5790acycloviracyclovirMajor PharmaceuticalsANDACurrent
0904-5790acycloviracyclovirMajor PharmaceuticalsANDACurrent
0904-5790acycloviracyclovirMajor PharmaceuticalsANDACurrent
12634-697acycloviracyclovirApotheca Inc.ANDACurrent
35356-903AcycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-903AcycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-903AcycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-903AcycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
43353-933AcycloviracyclovirAphena Pharma Solutions - Tennessee, LLCANDACurrent
49999-231acycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0637acycloviracyclovirA-S Medication SolutionsANDACurrent
50090-0637acycloviracyclovirA-S Medication SolutionsANDACurrent
50090-0642acycloviracyclovirA-S Medication SolutionsANDACurrent
50090-0643acycloviracyclovirA-S Medication SolutionsANDACurrent
60429-309acycloviracyclovirGolden State Medical Supply, Inc.ANDACurrent
60429-309acycloviracyclovirGolden State Medical Supply, Inc.ANDACurrent
60429-309acycloviracyclovirGolden State Medical Supply, Inc.ANDACurrent
60429-310acycloviracyclovirGolden State Medical Supply, Inc.ANDACurrent
60429-310acycloviracyclovirGolden State Medical Supply, Inc.ANDACurrent
60505-5306acycloviracyclovirApotex Corp.ANDACurrent
60505-5307acycloviracyclovirApotex Corp.ANDACurrent
61919-003ACYCLOVIRACYCLOVIRDIRECT RXANDACurrent
61919-003ACYCLOVIRACYCLOVIRDIRECT RXANDACurrent
61919-003ACYCLOVIRACYCLOVIRDIRECT RXANDACurrent
61919-003ACYCLOVIRACYCLOVIRDIRECT RXANDACurrent
63187-192acycloviracyclovirProficient Rx LPANDACurrent
63187-192acycloviracyclovirProficient Rx LPANDACurrent
63629-1192acycloviracyclovirBryant Ranch PrepackANDACurrent
63629-1193acycloviracyclovirBryant Ranch PrepackANDACurrent
63629-9174acycloviracyclovirBryant Ranch PrepackANDACurrent
63629-9174acycloviracyclovirBryant Ranch PrepackANDACurrent
63629-9174acycloviracyclovirBryant Ranch PrepackANDACurrent
67296-1034acycloviracyclovirRedPharm Drug, Inc.ANDACurrent
67296-1034acycloviracyclovirRedPharm Drug, Inc.ANDACurrent
67296-1034acycloviracyclovirRedPharm Drug, Inc.ANDACurrent
67296-1707acycloviracyclovirRedPharm DrugANDACurrent
67296-1707acycloviracyclovirRedPharm DrugANDACurrent
68071-2247acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2247acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2287acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2287acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2287acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5094acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5094acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5100acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5100acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68084-108AcyclovirAcyclovirAmerican Health PackagingANDACurrent
68084-108AcyclovirAcyclovirAmerican Health PackagingANDACurrent
68084-108AcyclovirAcyclovirAmerican Health PackagingANDACurrent
68084-109AcyclovirAcyclovirAmerican Health PackagingANDACurrent
68084-109AcyclovirAcyclovirAmerican Health PackagingANDACurrent
68084-109AcyclovirAcyclovirAmerican Health PackagingANDACurrent
68788-6360acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7760acycloviracyclovirPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7760acycloviracyclovirPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7760acycloviracyclovirPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7760acycloviracyclovirPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7895acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7895acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
68788-8989acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
70518-0427acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-0427acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-0427acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-0427acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-0427acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-0427acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70934-556acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-556acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-556acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-556acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-557acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-557acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-557acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-694acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-694acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-697acycloviracyclovirApotex Corp.ANDACurrent
71205-391acycloviracyclovirProficient Rx LPANDACurrent
71335-1381acycloviracyclovirBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9035ORIG2005-10-20