Application 203047
- Type
- ANDA
- Sponsor
- HETERO LABS LTD V
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 |
|---|---|---|---|---|---|---|---|
| A203047-001 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2015-04-08 | |
| A203047-002 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | RS | 2015-04-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203047-001 | AB |
| A203047-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203047-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2015-04-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203047-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2015-04-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203047-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2015-04-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203047-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2015-04-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203047-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2015-04-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203047-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2015-04-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203047-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2015-04-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203047-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2015-04-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203047-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2015-04-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203047-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2015-04-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203047-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2015-04-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203047-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2015-04-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203047-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2015-04-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203047-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2015-04-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203047-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2015-04-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203047-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2015-04-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203047-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2015-04-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203047-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2015-04-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203047-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2015-04-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203047-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2015-04-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203047-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2015-04-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203047-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2015-04-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203047-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2015-04-08 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203047-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2015-04-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203047-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2015-04-08 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203047-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2015-04-08 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A203047-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2015-04-08 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A203047-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2015-04-08 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203047-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2015-04-08 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203047-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2015-04-08 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A203047-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2015-04-08 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A203047-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2015-04-08 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A203047-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2015-04-08 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A203047-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2015-04-08 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A203047-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2015-04-08 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A203047-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2015-04-08 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A203047-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2015-04-08 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A203047-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2015-04-08 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A203047-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2015-04-08 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A203047-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2015-04-08 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203047-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203047-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203047-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203047-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203047-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203047-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203047-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203047-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203047-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203047-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203047-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203047-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203047-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203047-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203047-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203047-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203047-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203047-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203047-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203047-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203047-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203047-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203047-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203047-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203047-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203047-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A203047-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A203047-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203047-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203047-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A203047-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A203047-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A203047-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A203047-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A203047-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A203047-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A203047-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A203047-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A203047-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A203047-002 | AB | 1 | 782e0a99824c… |
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 | VALACYCLOVIR | REMEDYREPACK INC. | 7c332401-afb6-455b-b61a-ea108a377ef6 | 2026-07-23 | Warnings, Adverse reactions | 203047 ANDA203047 70518-2402 |
| Valacyclovir | VALACYCLOVIR | St Mary's Medical Park Pharmacy | bed99bed-3904-5278-e053-2a95a90aeab6 | 2026-06-20 | Warnings, Adverse reactions | 203047 ANDA203047 60760-469 |
| Valacyclovir | VALACYCLOVIR | PD-Rx Pharmaceuticals, Inc. | 1b11361c-5444-498b-ab7c-fbad917705ae | 2026-05-14 | Warnings, Adverse reactions | 203047 ANDA203047 43063-771 |
| Valacyclovir | VALACYCLOVIR | Coupler LLC | 5100ef9f-6dc2-fa06-e063-6294a90accd0 | 2026-05-04 | Warnings, Adverse reactions | 203047 ANDA203047 |
| Valacyclovir | VALACYCLOVIR | Coupler LLC | 50237c2d-99e8-9899-e063-6394a90a468c | 2026-04-23 | Warnings, Adverse reactions | 203047 ANDA203047 |
| Valacyclovir | VALACYCLOVIR | NuCare Pharmaceuticals,Inc. | 84601168-8829-f4a3-e053-2991aa0a3c20 | 2026-04-14 | Warnings, Adverse reactions | 203047 ANDA203047 68071-4805 |
| Valacyclovir | VALACYCLOVIR | PD-Rx Pharmaceuticals, Inc. | e6f54a83-eb07-49d6-b93a-6fe94db323b8 | 2026-03-20 | Warnings, Adverse reactions | 203047 ANDA203047 |
| Valacyclovir | VALACYCLOVIR | A-S Medication Solutions | 69301126-c901-4d0d-9acb-91ba1a87cd21 | 2026-02-18 | Warnings, Adverse reactions | 203047 ANDA203047 50090-2510 50090-2575 |
| Valacyclovir | VALACYCLOVIR | A-S Medication Solutions | 4ab809f3-8898-463c-b55a-f452c87d0779 | 2026-02-17 | Warnings, Adverse reactions | 203047 ANDA203047 |
| Valacyclovir | VALACYCLOVIR | Quallent Pharmaceuticals Health LLC | 764b0cf9-9207-404c-87a8-a1e0109af6cc | 2026-01-21 | Warnings, Adverse reactions | 203047 ANDA203047 82009-041 82009-040 |
| Valacyclovir | VALACYCLOVIR | Camber Pharmaceuticals, Inc. | 7f5e96e0-534c-47a5-bb79-926088afc73c | 2025-12-17 | Warnings, Adverse reactions | 203047 ANDA203047 31722-705 31722-704 |
| Valacyclovir | VALACYCLOVIR | Preferred Pharmaceuticals, Inc. | 7abc96b9-8f34-4fda-b5bb-1bdf23c1e135 | 2025-10-02 | Warnings, Adverse reactions | 203047 ANDA203047 68788-7587 |
| Valacyclovir | VALACYCLOVIR | NuCare Pharmaceuticals, Inc. | 296c04dc-2c64-4784-e063-6294a90ae6a3 | 2025-08-13 | Warnings, Adverse reactions | 203047 ANDA203047 |
| Valacyclovir | VALACYCLOVIR | REMEDYREPACK INC. | 2c2d5cec-038f-42bb-8f04-90d2431dc1c9 | 2025-08-04 | Warnings, Adverse reactions | 203047 ANDA203047 |
| Valacyclovir | VALACYCLOVIR | NuCare Pharmaceuticals, Inc. | 3aff1f5e-d92b-686b-e063-6294a90a2995 | 2025-07-28 | Warnings, Adverse reactions | 203047 ANDA203047 |
| Valacyclovir | VALACYCLOVIR | Proficient Rx LP | 90a67c02-edce-44aa-8d3a-d819313acc26 | 2025-06-02 | Warnings, Adverse reactions | 203047 ANDA203047 |
| Valacyclovir | VALACYCLOVIR | NuCare Pharmaceuticals, Inc. | 29a6b4ec-3e23-289b-e063-6394a90a1157 | 2024-12-24 | Warnings, Adverse reactions | 203047 ANDA203047 |
| Valacyclovir | VALACYCLOVIR | Bryant Ranch Prepack | e5f5223f-569c-40c6-a3c7-381bc61cf8c6 | 2024-08-28 | Warnings, Adverse reactions | 203047 ANDA203047 71335-0630 |
| Valacyclovir | VALACYCLOVIR | Proficient Rx LP | 8794a786-245a-42a3-b33a-9b0ed1dd46ac | 2023-09-01 | Warnings, Adverse reactions | 203047 ANDA203047 63187-950 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 31722-704 | Valacyclovir | Valacyclovir | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-704 | Valacyclovir | Valacyclovir | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-704 | Valacyclovir | Valacyclovir | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-705 | Valacyclovir | Valacyclovir | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-705 | Valacyclovir | Valacyclovir | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-705 | Valacyclovir | Valacyclovir | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 43063-771 | Valacyclovir | Valacyclovir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-771 | Valacyclovir | Valacyclovir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-771 | Valacyclovir | Valacyclovir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-771 | Valacyclovir | Valacyclovir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-771 | Valacyclovir | Valacyclovir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-771 | Valacyclovir | Valacyclovir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-771 | Valacyclovir | Valacyclovir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-771 | Valacyclovir | Valacyclovir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-2510 | Valacyclovir | Valacyclovir | A-S Medication Solutions | ANDA | Current |
| 50090-2510 | Valacyclovir | Valacyclovir | A-S Medication Solutions | ANDA | Current |
| 50090-2510 | Valacyclovir | Valacyclovir | A-S Medication Solutions | ANDA | Current |
| 50090-2510 | Valacyclovir | Valacyclovir | A-S Medication Solutions | ANDA | Current |
| 50090-2575 | Valacyclovir | Valacyclovir | A-S Medication Solutions | ANDA | Current |
| 50090-2575 | Valacyclovir | Valacyclovir | A-S Medication Solutions | ANDA | Current |
| 50090-2575 | Valacyclovir | Valacyclovir | A-S Medication Solutions | ANDA | Current |
| 50436-0704 | Valacyclovir | Valacyclovir | Unit Dose Services | ANDA | Current |
| 50436-7050 | Valacyclovir | Valacyclovir | Unit Dose Services | ANDA | Current |
| 50436-7050 | Valacyclovir | Valacyclovir | Unit Dose Services | ANDA | Current |
| 55700-913 | Valacyclovir | Valacyclovir | Quality Care Products, LLC | ANDA | Current |
| 55700-913 | Valacyclovir | Valacyclovir | Quality Care Products, LLC | ANDA | Current |
| 60760-469 | Valacyclovir | Valacyclovir | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 63187-950 | Valacyclovir | Valacyclovir | Proficient Rx LP | ANDA | Current |
| 63187-950 | Valacyclovir | Valacyclovir | Proficient Rx LP | ANDA | Current |
| 63629-7958 | Valacyclovir | Valacyclovir | Bryant Ranch Prepack | ANDA | Current |
| 63629-7958 | Valacyclovir | Valacyclovir | Bryant Ranch Prepack | ANDA | Current |
| 63739-077 | Valacyclovir | Valacyclovir | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 67296-1297 | Valacyclovir | Valacyclovir | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1297 | Valacyclovir | Valacyclovir | RedPharm Drug, Inc. | ANDA | Current |
| 68071-2753 | Valacyclovir | Valacyclovir | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3135 | Valacyclovir | Valacyclovir | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3135 | Valacyclovir | Valacyclovir | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3332 | Valacyclovir | Valacyclovir | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3332 | Valacyclovir | Valacyclovir | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4805 | Valacyclovir | Valacyclovir | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4805 | Valacyclovir | Valacyclovir | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7547 | Valacyclovir | Valacyclovir | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7587 | Valacyclovir | Valacyclovir | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7587 | Valacyclovir | Valacyclovir | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7587 | Valacyclovir | Valacyclovir | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7587 | Valacyclovir | Valacyclovir | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-2402 | Valacyclovir | Valacyclovir | REMEDYREPACK INC. | ANDA | Current |
| 70518-2402 | Valacyclovir | Valacyclovir | REMEDYREPACK INC. | ANDA | Current |
| 70518-2402 | Valacyclovir | Valacyclovir | REMEDYREPACK INC. | ANDA | Current |
| 70518-2402 | Valacyclovir | Valacyclovir | REMEDYREPACK INC. | ANDA | Current |
| 70934-106 | Valacyclovir | Valacyclovir | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-106 | Valacyclovir | Valacyclovir | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-106 | Valacyclovir | Valacyclovir | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71335-0630 | Valacyclovir | Valacyclovir | Bryant Ranch Prepack | ANDA | Current |
| 71335-0630 | Valacyclovir | Valacyclovir | Bryant Ranch Prepack | ANDA | Current |
| 71335-0630 | Valacyclovir | Valacyclovir | Bryant Ranch Prepack | ANDA | Current |
| 72189-051 | VALACYCLOVIR | VALACYCLOVIR | DIRECT RX | ANDA | Current |
| 72189-051 | VALACYCLOVIR | VALACYCLOVIR | DIRECT RX | ANDA | Current |
| 72189-051 | VALACYCLOVIR | VALACYCLOVIR | DIRECT RX | ANDA | Current |
| 82009-040 | Valacyclovir | Valacyclovir | Quallent Pharmaceuticals Health LLC | ANDA | Current |
| 82009-040 | Valacyclovir | Valacyclovir | Quallent Pharmaceuticals Health LLC | ANDA | Current |
| 82009-041 | Valacyclovir | Valacyclovir | Quallent Pharmaceuticals Health LLC | ANDA | Current |
| 82009-041 | Valacyclovir | Valacyclovir | Quallent Pharmaceuticals Health LLC | ANDA | Current |