Application 074556

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACYCLOVIRACYCLOVIRTABLET;ORAL200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
002ACYCLOVIRACYCLOVIRTABLET;ORAL400MGNoNo
003ACYCLOVIRACYCLOVIRTABLET;ORAL800MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074556-001ACYCLOVIRACYCLOVIR200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-04-22
A074556-002ACYCLOVIRACYCLOVIR400MGTABLET / ORALAB1997-04-22
A074556-003ACYCLOVIRACYCLOVIR800MGTABLET / ORALAB1997-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074556-002AB
A074556-003AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074556-001ACYCLOVIR200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-04-2284e616aacf4f…
2026-09-14 22:38:342026-08A074556-002ACYCLOVIR400MGTABLET / ORALAB1997-04-2284e616aacf4f…
2026-09-14 22:38:342026-08A074556-003ACYCLOVIR800MGTABLET / ORALAB1997-04-2284e616aacf4f…
2026-08-18 06:07:402026-07A074556-001ACYCLOVIR200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-04-22caaa826d4ba7…
2026-08-18 06:07:402026-07A074556-002ACYCLOVIR400MGTABLET / ORALAB1997-04-22caaa826d4ba7…
2026-08-18 06:07:402026-07A074556-003ACYCLOVIR800MGTABLET / ORALAB1997-04-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074556-001ACYCLOVIR200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074556-002ACYCLOVIR400MGTABLET / ORALAB1997-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074556-003ACYCLOVIR800MGTABLET / ORALAB1997-04-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074556-001ACYCLOVIR200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074556-002ACYCLOVIR400MGTABLET / ORALAB1997-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074556-003ACYCLOVIR800MGTABLET / ORALAB1997-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A074556-001ACYCLOVIR200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074556-002ACYCLOVIR400MGTABLET / ORALAB1997-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074556-003ACYCLOVIR800MGTABLET / ORALAB1997-04-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074556-001ACYCLOVIR200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-04-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074556-002ACYCLOVIR400MGTABLET / ORALAB1997-04-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074556-003ACYCLOVIR800MGTABLET / ORALAB1997-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074556-001ACYCLOVIR200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-04-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074556-002ACYCLOVIR400MGTABLET / ORALAB1997-04-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074556-003ACYCLOVIR800MGTABLET / ORALAB1997-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074556-001ACYCLOVIR200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-04-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074556-002ACYCLOVIR400MGTABLET / ORALAB1997-04-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074556-003ACYCLOVIR800MGTABLET / ORALAB1997-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074556-001ACYCLOVIR200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-04-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074556-002ACYCLOVIR400MGTABLET / ORALAB1997-04-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074556-003ACYCLOVIR800MGTABLET / ORALAB1997-04-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074556-001ACYCLOVIR200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-04-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074556-002ACYCLOVIR400MGTABLET / ORALAB1997-04-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074556-003ACYCLOVIR800MGTABLET / ORALAB1997-04-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074556-001ACYCLOVIR200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-04-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074556-002ACYCLOVIR400MGTABLET / ORALAB1997-04-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074556-003ACYCLOVIR800MGTABLET / ORALAB1997-04-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074556-001ACYCLOVIR200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-04-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A074556-002ACYCLOVIR400MGTABLET / ORALAB1997-04-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A074556-003ACYCLOVIR800MGTABLET / ORALAB1997-04-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074556-001ACYCLOVIR200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-04-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074556-002ACYCLOVIR400MGTABLET / ORALAB1997-04-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074556-003ACYCLOVIR800MGTABLET / ORALAB1997-04-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074556-001ACYCLOVIR200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-04-22301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A074556-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A074556-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A074556-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074556-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074556-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074556-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074556-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074556-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074556-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074556-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074556-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074556-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074556-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074556-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074556-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074556-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074556-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074556-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074556-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074556-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074556-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074556-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074556-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074556-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074556-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074556-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074556-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074556-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074556-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074556-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074556-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074556-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074556-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074556-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074556-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074556-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074556-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074556-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074556-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074556-003AB174a2ff9319b5…

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 3 of 9 · 174 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcyclovirACYCLOVIRAvet Pharmaceuticals Inc.4d5b5fd7-64ab-8275-e063-6394a90a22052026-03-25Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
ACYCLOVIRACYCLOVIRBryant Ranch Prepacke5356160-cb35-4ff6-91d5-2ade594e02792026-03-25Warnings, Adverse reactionsName fallback
brand name: ACYCLOVIR
generic name: ACYCLOVIR
AcyclovirACYCLOVIRBryant Ranch Prepack69e5455e-d0be-4c2b-b9ab-458b5480ed572026-03-16Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
acyclovirACYCLOVIRREMEDYREPACK INC.8fdabab2-bc93-48ab-9c13-d22ec90fdcfc2026-02-27Warnings, Adverse reactionsName fallback
brand name: acyclovir
generic name: ACYCLOVIR
AcyclovirACYCLOVIRFlorida Pharmaceutical Products, LLC3df7fa38-a869-45fb-98a3-81c5a2527d622026-02-18Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
AcyclovirACYCLOVIRMajor Pharmaceuticals46150f19-ce5d-42a0-80a7-f96fda2b98792026-02-18Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
AcyclovirACYCLOVIRPreferred Pharmaceuticals, Inc.b6d69697-12bb-4548-a6c3-2463cbf54f8f2026-02-11Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
AcyclovirACYCLOVIRA-S Medication Solutions2e6a3667-af06-40de-80c0-8c4346e0671f2026-02-08Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
AcyclovirACYCLOVIRCamber Pharmaceuticals, Inc.0910335b-6796-459f-b97e-d7ef5439a0602026-02-02Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
acyclovirACYCLOVIRGlenmark Pharmaceuticals Inc., USA149f4418-7668-4d34-a6f9-69bf3a9c50492026-01-28Warnings, Adverse reactionsName fallback
brand name: acyclovir
generic name: ACYCLOVIR
acyclovirACYCLOVIRANI Pharmaceuticals, Inc.8208711c-18ba-4615-b932-3c0bb7e6efae2026-01-23Warnings, Adverse reactionsName fallback
brand name: acyclovir
generic name: ACYCLOVIR
AcyclovirACYCLOVIRActavis Pharma, Inc.a4c1305c-f18c-4fb0-83d8-2822341f2dfa2026-01-21Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
AcyclovirACYCLOVIRPreferred Pharmaceuticals Inc75334fc5-d236-401a-875c-f4f9c7749c1a2026-01-19Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
acyclovirACYCLOVIRPreferred Pharmaceuticals Incc11c1136-7421-48ff-86d2-39507e80a04c2026-01-15Warnings, Adverse reactionsName fallback
brand name: acyclovir
generic name: ACYCLOVIR
AcyclovirACYCLOVIRPreferred Pharmaceuticals Inc.b1033fda-8242-4006-b1cd-23474d70671f2026-01-15Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
AcyclovirACYCLOVIRAvPAK6e203fa9-ee97-1e08-8d6a-fb57cfa13e192026-01-08Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
AcyclovirACYCLOVIRCadila Pharmaceuticals Limiteddbaf4bf5-57e3-4770-a9b2-d47649e54c1b2026-01-02Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
AcyclovirACYCLOVIRNorthwind Health Company, LLC5dcfd21c-43f0-469c-be70-a4e74e6ccf882026-01-01Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
AcyclovirACYCLOVIRNorthwind Health Company, LLCf6f56143-ea74-af87-e053-6394a90ae3462026-01-01Warnings, Adverse reactionsName fallback
brand name: Acyclovir
generic name: ACYCLOVIR
acyclovirACYCLOVIRNorthwind Health Company, LLCff9776b3-a248-e1ea-e053-6294a90aeb7b2026-01-01Warnings, Adverse reactionsName fallback
brand name: acyclovir
generic name: ACYCLOVIR

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-8943AcyclovirAcyclovirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8947AcyclovirAcyclovirTeva Pharmaceuticals USA, Inc.ANDACurrent
10544-102AcyclovirAcyclovirBlenheim Pharmacal, Inc.ANDACurrent
10544-103AcyclovirAcyclovirBlenheim Pharmacal, Inc.ANDACurrent
12634-520AcyclovirAcyclovirApotheca Inc.ANDACurrent
33261-227AcyclovirAcyclovirAidarex Pharmaceuticals LLCANDACurrent
33261-491AcyclovirAcyclovirAidarex Pharmaceuticals LLCANDACurrent
42708-073AcyclovirAcyclovirQPharma IncANDACurrent
42708-073AcyclovirAcyclovirQPharma IncANDACurrent
52959-544AcyclovirAcyclovirH.J. Harkins Company Inc.ANDACurrent
53808-0821AcyclovirAcyclovirState of Florida DOH Central PharmacyANDACurrent
53808-0894AcyclovirAcyclovirState of Florida DOH Central PharmacyANDACurrent
55289-462AcyclovirAcyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-629AcyclovirAcyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
58118-8943AcyclovirAcyclovirClinical Solutions WholesaleANDACurrent
58118-8943AcyclovirAcyclovirClinical Solutions WholesaleANDACurrent
63629-1677AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-6349AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-6349AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-6376AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-6376AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
66116-414AcyclovirAcyclovirMedVantx, Inc.ANDACurrent
67296-1054AcyclovirAcyclovirRedPharm Drug, Inc.ANDACurrent
67296-1054AcyclovirAcyclovirRedPharm Drug, Inc.ANDACurrent
67296-1219AcyclovirAcyclovirRedPharm Drug, Inc.ANDACurrent
67296-1219AcyclovirAcyclovirRedPharm Drug, Inc.ANDACurrent
70518-0065AcyclovirAcyclovirREMEDYREPACK INC.ANDACurrent
70518-0065AcyclovirAcyclovirREMEDYREPACK INC.ANDACurrent
70518-0065AcyclovirAcyclovirREMEDYREPACK INC.ANDACurrent
70518-0798AcyclovirAcyclovirREMEDYREPACK INC.ANDACurrent
70518-0798AcyclovirAcyclovirREMEDYREPACK INC.ANDACurrent