Application 090216
- Type
- ANDA
- Sponsor
- WOCKHARDT
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 |
|---|---|---|---|---|---|---|---|
| A090216-001 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | |
| A090216-002 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090216-001 | AB |
| A090216-002 | 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 | A090216-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090216-002 | 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 | A090216-001 | 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 | A090216-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090216-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090216-002 | 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 | A090216-001 | 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 | A090216-002 | 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 | A090216-001 | 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 | A090216-002 | 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 | A090216-001 | 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 | A090216-002 | 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 | A090216-001 | 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 | A090216-002 | 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 | A090216-001 | 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 | A090216-002 | 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 | A090216-001 | 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 | A090216-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090216-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090216-002 | 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 | A090216-001 | 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 | A090216-002 | 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 | A090216-001 | 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 | A090216-002 | 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 | A090216-001 | 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 | A090216-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090216-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090216-002 | 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 | A090216-001 | 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 | A090216-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090216-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090216-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090216-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090216-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090216-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090216-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A090216-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A090216-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A090216-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A090216-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 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 | A090216-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090216-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090216-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090216-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090216-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090216-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090216-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090216-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090216-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090216-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090216-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090216-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090216-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090216-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090216-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090216-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090216-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090216-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090216-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090216-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090216-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090216-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090216-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090216-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090216-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090216-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090216-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A090216-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090216-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090216-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090216-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090216-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090216-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090216-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090216-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090216-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090216-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090216-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A090216-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A090216-002 | 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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 53217-054 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 55648-152 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | Wockhardt Limited | ANDA | Current |
| 55648-153 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | Wockhardt Limited | ANDA | Current |
| 64679-152 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | Wockhardt USA LLC. | ANDA | Current |
| 64679-152 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | Wockhardt USA LLC. | ANDA | Current |
| 64679-152 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | Wockhardt USA LLC. | ANDA | Current |
| 64679-153 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | Wockhardt USA LLC. | ANDA | Current |
| 64679-153 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | Wockhardt USA LLC. | ANDA | Current |
| 64679-153 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | Wockhardt USA LLC. | ANDA | Current |
| 68788-9554 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ANDA | Current |