Application 204314

Type
ANDA
Sponsor
ZYDUS PHARMS

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
A204314-001ACYCLOVIRACYCLOVIR400MGTABLET / ORALAB2014-08-19
A204314-002ACYCLOVIRACYCLOVIR800MGTABLET / ORALAB2014-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204314-001AB
A204314-002AB

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 UTC2026-02A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-19782e0a99824c…
2021-12-28 21:50 UTC2021-12A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-19782e0a99824c…

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 UTC2026-02A204314-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204314-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204314-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204314-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204314-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204314-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204314-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204314-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204314-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204314-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204314-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204314-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204314-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204314-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204314-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204314-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204314-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204314-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204314-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204314-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204314-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204314-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204314-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204314-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204314-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204314-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204314-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204314-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204314-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204314-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204314-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204314-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204314-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204314-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204314-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204314-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204314-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204314-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204314-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A204314-002AB1782e0a99824c…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
acyclovirACYCLOVIRNorthwind Health Company, LLC50c58161-3944-7367-e063-6394a90a62862026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204314
application number: ANDA204314
acyclovirACYCLOVIRREMEDYREPACK INC.960e4ede-692e-4db2-a96e-dc6f4a6190ee2026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204314
application number: ANDA204314
ndc (product): 70518-1614
acyclovirACYCLOVIRREMEDYREPACK INC.8fdabab2-bc93-48ab-9c13-d22ec90fdcfc2026-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204314
application number: ANDA204314
ndc (product): 70518-1363
acyclovirACYCLOVIRZydus Lifesciences Limited8d9fea43-6c04-40d7-8aac-398c2de2a5582025-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204314
application number: ANDA204314
ndc (product): 65841-803
ndc (product): 65841-802
acyclovirACYCLOVIRZydus Pharmaceuticals (USA) Inc.edb0cd28-ee57-4b60-be94-62c797fbf5e62025-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204314
application number: ANDA204314
ndc (product): 68382-791
ndc (product): 68382-792
acyclovirACYCLOVIRCoupler LLC2cdbea8d-29df-0045-e063-6294a90a95062025-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204314
application number: ANDA204314
acyclovirACYCLOVIRNuCare Pharmaceuticals, Inc.40e5cc54-ed74-3369-e054-00144ff88e882024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204314
application number: ANDA204314
ndc (product): 66267-399
acyclovirACYCLOVIRA-S Medication Solutionsf3e6b1ad-810b-4f53-b92a-b28fc2111f3f2024-01-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204314
application number: ANDA204314
ndc (product): 50090-3254
acyclovirACYCLOVIRA-S Medication Solutionsc40a57b9-4cf1-4a69-abf3-eb99a7fcda002023-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204314
application number: ANDA204314
ndc (product): 50090-3250
acyclovirACYCLOVIRProficient Rx LP3da54b2d-a206-4ff5-8cc2-90762c4fd70d2021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204314
application number: ANDA204314
ndc (product): 63187-366

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 94 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3250acycloviracyclovirA-S Medication SolutionsANDACurrent
50090-3250acycloviracyclovirA-S Medication SolutionsANDACurrent
50090-3250acycloviracyclovirA-S Medication SolutionsANDACurrent
50090-3254acycloviracyclovirA-S Medication SolutionsANDACurrent
50090-3254acycloviracyclovirA-S Medication SolutionsANDACurrent
50090-3795acycloviracyclovirA-S Medication SolutionsANDACurrent
50090-3795acycloviracyclovirA-S Medication SolutionsANDACurrent
50090-3795acycloviracyclovirA-S Medication SolutionsANDACurrent
50436-0792acycloviracyclovirUnit Dose ServicesANDACurrent
53217-188acycloviracyclovirAidarex Pharmaceuticals LLCANDACurrent
55700-663acycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-663acycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-663acycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-664acycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-664acycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-664acycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-664acycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
58118-0791acycloviracyclovirClinical Solutions Wholesale, LLCANDACurrent
58118-0791acycloviracyclovirClinical Solutions Wholesale, LLCANDACurrent
58118-0791acycloviracyclovirClinical Solutions Wholesale, LLCANDACurrent
63187-366acycloviracyclovirProficient Rx LPANDACurrent
63187-366acycloviracyclovirProficient Rx LPANDACurrent
63629-7613acycloviracyclovirBryant Ranch PrepackANDACurrent
63629-7613acycloviracyclovirBryant Ranch PrepackANDACurrent
63629-7613acycloviracyclovirBryant Ranch PrepackANDACurrent
63629-7613acycloviracyclovirBryant Ranch PrepackANDACurrent
63629-7975acycloviracyclovirBryant Ranch PrepackANDACurrent
63629-7975acycloviracyclovirBryant Ranch PrepackANDACurrent
63629-7975acycloviracyclovirBryant Ranch PrepackANDACurrent
65841-802acycloviracyclovirZydus Lifesciences LimitedANDACurrent
65841-802acycloviracyclovirCadila Healthcare LimitedANDACurrent
65841-802acycloviracyclovirCadila Healthcare LimitedANDACurrent
65841-803acycloviracyclovirZydus Lifesciences LimitedANDACurrent
65841-803acycloviracyclovirCadila Healthcare LimitedANDACurrent
65841-803acycloviracyclovirCadila Healthcare LimitedANDACurrent
66267-007acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
66267-007acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
66267-399acycloviracyclovirNuCare Pharmaceuticals, IANDACurrent
66267-399acycloviracyclovirNuCare Pharmaceuticals, Inc.ANDACurrent
66267-399acycloviracyclovirNuCare Pharmaceuticals, Inc.ANDACurrent
67296-1185acycloviracyclovirRedPharm Drug, Inc.ANDACurrent
67296-1185acycloviracyclovirRedPharm Drug, Inc.ANDACurrent
67296-1185acycloviracyclovirRedPharm Drug, Inc.ANDACurrent
67296-1185acycloviracyclovirRedPharm Drug, Inc.ANDACurrent
67296-1193acycloviracyclovirRedPharm Drug, Inc.ANDACurrent
67296-1193acycloviracyclovirRedPharm Drug, Inc.ANDACurrent
67296-1193acycloviracyclovirRedPharm Drug, Inc.ANDACurrent
68071-4559acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68382-791acycloviracyclovirZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-791acycloviracyclovirZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-791acycloviracyclovirZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-792acycloviracyclovirZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-792acycloviracyclovirZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-792acycloviracyclovirZydus Pharmaceuticals (USA) Inc.ANDACurrent
68788-7378acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7378acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7378acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7378acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7382acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7382acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7382acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7382acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
69677-104AcyclovirAcyclovirMAS MANAGEMENT GROUP, INC.ANDACurrent
69677-105AcyclovirAcyclovirMAS MANAGEMENT GROUP, INC.ANDACurrent
70518-0018acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-1332acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-1332acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-1332acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-1332acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-1332acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-1363acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-1363acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-1614acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-1614acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70934-131acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-131acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-131acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-131acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-131acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-132acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent