Application 077478
- Type
- ANDA
- Sponsor
- SANDOZ
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 |
|---|---|---|---|---|---|---|---|
| A077478-001 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | ||
| A077478-002 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077478-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077478-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077478-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077478-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077478-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077478-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077478-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077478-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077478-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077478-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077478-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077478-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077478-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077478-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077478-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077478-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077478-001 | 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 | A077478-002 | 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 | A077478-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077478-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077478-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077478-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077478-001 | 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 | A077478-002 | 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 | A077478-001 | 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 | A077478-002 | 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 | A077478-001 | 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 | A077478-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077478-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077478-002 | 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 | A077478-001 | 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 | A077478-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077478-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077478-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077478-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077478-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077478-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077478-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077478-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077478-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077478-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077478-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077478-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077478-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077478-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077478-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077478-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077478-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077478-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A077478-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077478-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077478-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077478-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077478-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077478-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A077478-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077478-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077478-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077478-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A077478-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A077478-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A077478-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077478-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077478-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A077478-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A077478-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A077478-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A077478-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A077478-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A077478-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A077478-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077478-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077478-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077478-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077478-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077478-002 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077478-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077478-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A077478-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A077478-002 | AB | 1 | 1c564ffb4f44… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-5208 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-5208 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Sandoz Inc. | ANDA | Current |
| 0781-5208 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Sandoz Inc. | ANDA | Current |
| 0781-5208 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Sandoz Inc. | ANDA | Current |
| 0781-5209 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-5209 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Sandoz Inc. | ANDA | Current |
| 0781-5209 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Sandoz Inc. | ANDA | Current |
| 0781-5209 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Sandoz Inc. | ANDA | Current |
| 61919-919 | Valacyclovir | Valacyclovir | Direct Rx | ANDA | Current |
| 68788-9432 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-2329 | Valacyclovir Hydrochloride | Valacyclovir Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 75921-208 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | Life Line Home Care Services, Inc. | ANDA | Current |