Application 090216

Type
ANDA
Sponsor
WOCKHARDT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDETABLET;ORALEQ 500MG BASENoNo
002VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDETABLET;ORALEQ 1GM BASENoNo

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
A090216-001VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24
A090216-002VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090216-001AB
A090216-002AB

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 UTC2026-02A090216-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090216-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090216-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090216-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A090216-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090216-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090216-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090216-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090216-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090216-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090216-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090216-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090216-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090216-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090216-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090216-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090216-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090216-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090216-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A090216-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090216-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090216-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090216-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090216-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090216-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090216-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090216-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090216-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090216-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090216-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090216-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090216-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090216-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090216-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090216-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090216-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090216-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090216-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090216-001VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2010-05-24782e0a99824c…
2021-12-28 21:50 UTC2021-12A090216-002VALACYCLOVIR HYDROCHLORIDEEQ 1GM BASETABLET / ORALAB2010-05-24782e0a99824c…

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 UTC2026-02A090216-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090216-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090216-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090216-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090216-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090216-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090216-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090216-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090216-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090216-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090216-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090216-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090216-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090216-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090216-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090216-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090216-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090216-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090216-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090216-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090216-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090216-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090216-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090216-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090216-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090216-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090216-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090216-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090216-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090216-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090216-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090216-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090216-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090216-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090216-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090216-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090216-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090216-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090216-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090216-002AB1782e0a99824c…

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 3 · 51 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEREMEDYREPACK INC.740bbed7-b2dd-4ad9-99e0-03a9f1d61e3f2026-07-22Warnings, Adverse reactionsName fallback
brand name: Valacyclovir Hydrochloride
generic name: VALACYCLOVIR HYDROCHLORIDE
VALTREXVALACYCLOVIR HYDROCHLORIDEREMEDYREPACK INC.56a62c21-bead-4f3b-a24e-c3fd0b4a732f2026-07-16Warnings, Adverse reactionsName fallback
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEREMEDYREPACK INC.1ecd2332-4c60-46c1-a175-774926ffc6c62026-06-26Warnings, Adverse reactionsName fallback
brand name: Valacyclovir Hydrochloride
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIRNorthwind Health Company, LLC1b53c6bb-0e8c-f49a-e063-6294a90a0f5a2026-06-24Warnings, Adverse reactionsName fallback
brand name: Valacyclovir Hydrochloride
Valacyclovir HydrochlorideVALACYCLOVIRNorthwind Health Company, LLC5036e5f8-e659-6010-e063-6294a90af9472026-06-24Warnings, Adverse reactionsName fallback
brand name: Valacyclovir Hydrochloride
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEBryant Ranch Prepacka56f37e1-dcc2-4fb1-ae39-bb20b9b7a3d32026-06-16Warnings, Adverse reactionsName fallback
brand name: Valacyclovir Hydrochloride
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEBryant Ranch Prepackc28c069f-3b51-4474-aa38-1aed6b7b86782026-06-12Warnings, Adverse reactionsName fallback
brand name: Valacyclovir Hydrochloride
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDESt. Mary's Medical Park Pharmacy275c0198-10a5-139e-e063-6394a90a72be2026-06-04Warnings, Adverse reactionsName fallback
brand name: Valacyclovir Hydrochloride
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEBryant Ranch Prepack93dccd99-d28b-4c47-872c-c3c0001b8a7f2026-06-04Warnings, Adverse reactionsName fallback
brand name: Valacyclovir Hydrochloride
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIRSafecor Health LLC021ab9d0-7b75-40cf-afde-446942d643882026-05-28Warnings, Adverse reactionsName fallback
brand name: Valacyclovir Hydrochloride
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1a888812-2867-4dd3-b56e-2d98da837d1f2026-05-12Warnings, Adverse reactionsName fallback
brand name: Valacyclovir Hydrochloride
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDENorthStar Rx LLC4acf51de-26f7-42b2-8acc-61b800627ef32026-05-12Warnings, Adverse reactionsName fallback
brand name: Valacyclovir Hydrochloride
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDESportpharm LLC7681a6f4-a6e7-4277-adbd-38837d5ead6b2026-04-24Warnings, Adverse reactionsName fallback
brand name: Valacyclovir Hydrochloride
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEREMEDYREPACK INC.de96c14b-cd74-46dd-bcce-d1fa640a60372026-04-08Warnings, Adverse reactionsName fallback
brand name: Valacyclovir Hydrochloride
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEA-S Medication Solutions8c0be4f6-2d11-41d4-8f57-4f8db9da60b22026-03-24Warnings, Adverse reactionsName fallback
brand name: Valacyclovir Hydrochloride
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEMajor Pharmaceuticalsfd982aee-d503-47b3-8d3d-42e9a86904572026-03-24Warnings, Adverse reactionsName fallback
brand name: Valacyclovir Hydrochloride
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEA-S Medication Solutions87ec59e3-c06a-4ca7-bc65-5b251263ab3b2026-03-17Warnings, Adverse reactionsName fallback
brand name: Valacyclovir Hydrochloride
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEA-S Medication Solutionsdf34e11d-5f2c-4755-b84b-b95d1d7b73f02026-03-17Warnings, Adverse reactionsName fallback
brand name: Valacyclovir Hydrochloride
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDERising Pharma Holdings, Inc.8d1645c0-fd03-4992-9372-98026a26b3af2026-03-10Warnings, Adverse reactionsName fallback
brand name: Valacyclovir Hydrochloride
generic name: VALACYCLOVIR HYDROCHLORIDE
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ae8d15a4-1ed5-4e3c-9672-0f4735322a1c2026-02-25Warnings, Adverse reactionsName fallback
brand name: Valacyclovir Hydrochloride
generic name: VALACYCLOVIR HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
53217-054VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEAidarex Pharmaceuticals LLCANDACurrent
55648-152VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEWockhardt LimitedANDACurrent
55648-153VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEWockhardt LimitedANDACurrent
64679-152VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-152VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-152VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-153VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-153VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-153VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
68788-9554VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEPreferred Pharmaceuticals, Inc.ANDACurrent