Application 090682
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | TABLET;ORAL | EQ 500MG BASE | No | No |
| 002 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | TABLET;ORAL | EQ 1GM BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090682-001 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | |
| A090682-002 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090682-001 | AB |
| A090682-002 | AB |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090682-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090682-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090682-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090682-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090682-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090682-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090682-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090682-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090682-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090682-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090682-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090682-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090682-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090682-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090682-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090682-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090682-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090682-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090682-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090682-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090682-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090682-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090682-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090682-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090682-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090682-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090682-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090682-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090682-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090682-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090682-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A090682-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090682-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090682-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090682-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090682-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090682-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090682-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090682-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090682-002 | AB | 1 | 74a2ff9319b5… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | Proficient Rx LP | fb875f07-e9a0-48eb-a8b0-16ea7bbae9ab | 2026-01-01 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | Aurobindo Pharma Limited | f5cfb61e-d971-4a9c-b9ef-4f3368fe02f5 | 2025-12-04 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | AvPAK | 7f5fc62f-d043-db36-ce92-7adc4f7a79a5 | 2025-10-15 | Warnings, Adverse reactions | 090682 ANDA090682 50268-789 50268-788 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 82ddec27-79ac-40f4-afde-707f3940f893 | 2025-07-31 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | NuCare Pharmacuticals,Inc. | 552b806d-97d2-364d-e054-00144ff8d46c | 2025-05-28 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 802308ed-8c26-fed5-e053-2a91aa0a42b0 | 2025-04-24 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 82bac944-417a-0af7-e053-2a91aa0a8674 | 2025-03-17 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 8422aeeb-0c3b-478d-82fb-ca051809db01 | 2025-02-03 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | American Health Packaging | 23fb4162-2310-486c-ba9f-f7c94b793e56 | 2025-01-08 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 8022eb52-da04-eb0a-e053-2a91aa0a6f87 | 2024-12-02 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | e005139e-6f76-9b2f-e053-2a95a90ab0fb | 2024-11-08 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | Bryant Ranch Prepack | 4619bcc6-0070-4f3b-9cf9-900f3e5f7b19 | 2024-08-28 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | Asclemed USA, Inc. | 1864bf8b-07a2-4b82-8592-bf8ad6f9f8f9 | 2024-07-11 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 883f643b-27f6-5a3e-e053-2995a90a8ff1 | 2024-06-14 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | Proficient Rx LP | c6328ed5-a3d3-4948-94be-b226271d0311 | 2022-05-02 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | Proficient Rx LP | 268af320-810a-48de-9a08-9850be2878e3 | 2022-03-01 | Warnings, Adverse reactions | 090682 ANDA090682 63187-776 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | Asclemed USA, Inc. | b99b8309-dd80-422a-9b17-f20386dc4d8d | 2020-10-24 | Warnings, Adverse reactions | 090682 ANDA090682 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-6565 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6565 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6565 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6565 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 16714-697 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-697 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-697 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-697 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-697 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-697 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-697 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-698 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-698 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-698 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-698 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-698 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-698 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-698 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 43063-730 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-730 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-730 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-730 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-730 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-730 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-730 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-730 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-730 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-730 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43353-883 | Valacyclovir | Valacyclovir Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-883 | Valacyclovir | Valacyclovir Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50090-1173 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1173 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2223 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2223 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2223 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2224 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2224 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2224 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2224 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3875 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3875 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3880 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3880 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3880 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3880 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5852 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50268-788 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | AvPAK | ANDA | Current |
| 50268-788 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | AvPAK | ANDA | Current |
| 50268-788 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | AvPAK | ANDA | Current |
| 50268-788 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | AvPAK | ANDA | Current |
| 50268-789 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | AvPAK | ANDA | Current |
| 50268-789 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | AvPAK | ANDA | Current |
| 50268-789 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | AvPAK | ANDA | Current |
| 50268-789 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | AvPAK | ANDA | Current |
| 52343-051 | Valacyclovir | valacyclovir hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-051 | Valacyclovir | valacyclovir hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-052 | Valacyclovir | valacyclovir hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-052 | Valacyclovir | valacyclovir hydrochloride | ACETRIS HEALTH, LLC | ANDA | Current |
| 53002-0061 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-0061 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-7830 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-7830 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55154-6837 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-6837 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-6837 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-7985 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Cardinal Health 107, LLC | ANDA | Current |
| 55154-7985 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-7985 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Cardinal Health | ANDA | Current |
| 55700-045 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 57237-042 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-042 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-042 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-042 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-043 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-043 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-043 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-043 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Rising Health, LLC | ANDA | Current |
| 63187-776 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-776 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-776 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Proficient Rx LP | ANDA | Current |