Application 075382

Type
ANDA
Sponsor
CARLSBAD

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
A075382-001ACYCLOVIRACYCLOVIR400MGTABLET / ORALAB1999-04-30
A075382-002ACYCLOVIRACYCLOVIR800MGTABLET / ORALAB1999-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075382-001AB
A075382-002AB

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 UTC2026-02A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30782e0a99824c…
2021-12-28 21:50 UTC2021-12A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30782e0a99824c…

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 UTC2026-02A075382-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075382-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075382-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075382-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075382-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075382-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075382-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075382-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075382-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075382-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075382-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075382-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075382-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075382-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075382-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075382-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075382-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075382-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075382-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075382-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075382-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075382-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075382-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075382-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075382-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075382-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075382-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075382-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075382-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075382-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075382-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075382-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075382-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075382-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075382-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075382-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075382-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075382-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075382-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075382-002AB1782e0a99824c…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcyclovirACYCLOVIRCardinal Health 107, LLCd8004652-86fe-4714-81d4-5e1dd2585bb42026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
ndc (product): 55154-4332
AcyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.c2d9940a-ce88-5fd0-e053-2a95a90a4bc82026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
ndc (product): 68071-2408
AcyclovirACYCLOVIRAvPAK6e203fa9-ee97-1e08-8d6a-fb57cfa13e192026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
ndc (product): 50268-061
ndc (product): 50268-062
AcyclovirACYCLOVIRBryant Ranch Prepackf3cbd634-77c8-3306-bdbd-a4598b20603e2024-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
ndc (product): 63629-1678
AcyclovirACYCLOVIRBryant Ranch Prepacke0f17e6f-63c7-4828-8585-91fc582df30b2024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepackf09cdb3f-dfd2-4e47-bb5e-a5d26d8bcc892024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepack8c5d1f30-2d31-417d-860b-7228b7baaa642024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRGolden State Medical Supply, Inc.785d68bc-0bbf-b69d-e053-2991aa0ac0d52024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
ndc (product): 51407-146
ndc (product): 51407-145
AcyclovirACYCLOVIRBryant Ranch Prepack89583890-186b-4a7a-8741-41f6c5f0a99d2024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRCarlsbad Technology, Inc.a68e610a-841c-4b69-9233-673d060561e82024-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
ndc (product): 61442-112
ndc (product): 61442-113
AcyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.c46d5033-b1b2-e213-e053-2995a90ae6a32024-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
ndc (product): 68071-2447
AcyclovirACYCLOVIRProficient Rx LP33630a35-346e-43b6-9286-89e28ac0094a2022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 105 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42254-133AcycloviracyclovirRebel Distributors CorpANDACurrent
42254-198AcycloviracyclovirRebel Distributors CorpANDACurrent
43063-340AcyclovirAcyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-340AcyclovirAcyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-340AcyclovirAcyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-340AcyclovirAcyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-340AcyclovirAcyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-340AcyclovirAcyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-0638AcyclovirAcyclovirA-S Medication SolutionsANDACurrent
50090-0638AcyclovirAcyclovirA-S Medication SolutionsANDACurrent
50090-0644AcyclovirAcyclovirA-S Medication SolutionsANDACurrent
50090-0644AcyclovirAcyclovirA-S Medication SolutionsANDACurrent
50090-0644AcyclovirAcyclovirA-S Medication SolutionsANDACurrent
50090-0644AcyclovirAcyclovirA-S Medication SolutionsANDACurrent
50090-0645AcyclovirAcyclovirA-S Medication SolutionsANDACurrent
50090-0645AcyclovirAcyclovirA-S Medication SolutionsANDACurrent
50090-0645AcyclovirAcyclovirA-S Medication SolutionsANDACurrent
50090-2382AcyclovirAcyclovirA-S Medication SolutionsANDACurrent
50090-2383AcyclovirAcyclovirA-S Medication SolutionsANDACurrent
50268-061AcyclovirAcyclovirAvPAKANDACurrent
50268-061AcyclovirAcyclovirAvPAKANDACurrent
50268-062AcyclovirAcyclovirAvPAKANDACurrent
50268-062AcyclovirAcyclovirAvPAKANDACurrent
51407-145AcyclovirAcyclovirGolden State Medical Supply IncANDACurrent
51407-145AcyclovirAcyclovirGolden State Medical SupplyANDACurrent
51407-145AcyclovirAcyclovirGolden State Medical SupplyANDACurrent
51407-146AcyclovirAcyclovirGolden State Medical Supply IncANDACurrent
51407-146AcyclovirAcyclovirGolden State Medical SupplyANDACurrent
51407-146AcyclovirAcyclovirGolden State Medical SupplyANDACurrent
51655-099acyclovirAcyclovirNorthwind PharmaceuticalsANDACurrent
51655-678ACYCLOVIRACYCLOVIRNorthwind PharmaceuticalsANDACurrent
53002-0082AcyclovirAcyclovirRPK Pharmaceuticals, Inc.ANDACurrent
53002-0271AcyclovirAcyclovirRPK Pharmaceuticals, Inc.ANDACurrent
53217-313AcyclovirAcyclovirAidarex Pharmaceuticals LLCANDACurrent
53808-0628AcyclovirAcyclovirState of Florida DOH Central PharmacyANDACurrent
55154-4332AcyclovirAcyclovirCardinal HealthANDACurrent
55154-4332AcyclovirAcyclovirCardinal Health 107, LLCANDACurrent
55154-4332AcyclovirAcyclovirCardinal HealthANDACurrent
55154-4332AcyclovirAcyclovirCardinal HealthANDACurrent
55154-4332AcyclovirAcyclovirCardinal HealthANDACurrent
55700-539AcyclovirAcyclovirQuality Care Products, LLCANDACurrent
55700-539AcyclovirAcyclovirQuality Care Products, LLCANDACurrent
55700-539AcyclovirAcyclovirQuality Care Products, LLCANDACurrent
55700-835AcyclovirAcyclovirQuality Care Products, LLCANDACurrent
55700-835AcyclovirAcyclovirQuality Care Products, LLCANDACurrent
61442-112AcyclovirAcyclovirCarlsbad Technology, Inc.ANDACurrent
61442-112AcyclovirAcyclovirCarlsbad Technology, Inc.ANDACurrent
61442-112AcyclovirAcyclovirCarlsbad Technology, Inc.ANDACurrent
61442-113AcyclovirAcyclovirCarlsbad Technology, Inc.ANDACurrent
61442-113AcyclovirAcyclovirCarlsbad Technology, Inc.ANDACurrent
61442-113AcyclovirAcyclovirCarlsbad Technology, Inc.ANDACurrent
61919-370ACYCLOVIRACYCLOVIRDirect RXANDACurrent
61919-370ACYCLOVIRACYCLOVIRDirect RXANDACurrent
61919-370ACYCLOVIRACYCLOVIRDirect RXANDACurrent
61919-370ACYCLOVIRACYCLOVIRDirect RXANDACurrent
61919-370ACYCLOVIRACYCLOVIRDirect RXANDACurrent
63629-1005AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-1005AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-1005AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-1005AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-1006AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-1006AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-1006AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-1006AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-1678AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-1678AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-7638AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-7638AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-7639AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-7639AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63739-682AcyclovirAcyclovirMcKesson Corporation dba SKY PackagingANDACurrent
63739-682AcyclovirAcyclovirMcKesson CorporationANDACurrent
63739-682AcyclovirAcyclovirMcKesson Corporation dba SKY PackagingANDACurrent
67296-0710AcyclovirAcyclovirRedPharm Drug, Inc.ANDACurrent
67296-0710AcyclovirAcyclovirRedPharm Drug, Inc.ANDACurrent
68071-2408AcyclovirAcyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2447AcyclovirAcyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2501AcyclovirAcyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2506AcyclovirAcyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68788-0504AcyclovirAcyclovirPreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42986ORIG2007-04-09
30866ORIG1999-04-30