Application 077309
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACYCLOVIR | ACYCLOVIR | TABLET;ORAL | 400MG | No | No |
| 002 | ACYCLOVIR | ACYCLOVIR | TABLET;ORAL | 800MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077309-001 | ACYCLOVIR | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2005-09-29 | |
| A077309-002 | ACYCLOVIR | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2005-09-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077309-001 | AB |
| A077309-002 | 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 | A077309-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2005-09-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077309-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2005-09-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077309-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2005-09-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077309-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2005-09-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077309-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2005-09-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077309-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2005-09-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077309-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2005-09-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077309-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2005-09-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077309-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2005-09-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077309-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2005-09-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077309-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2005-09-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077309-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2005-09-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077309-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2005-09-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077309-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2005-09-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077309-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2005-09-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077309-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2005-09-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077309-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2005-09-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077309-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2005-09-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077309-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2005-09-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077309-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2005-09-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077309-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2005-09-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077309-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2005-09-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077309-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2005-09-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077309-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2005-09-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077309-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2005-09-29 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077309-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2005-09-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077309-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2005-09-29 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077309-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2005-09-29 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077309-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2005-09-29 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077309-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2005-09-29 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077309-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2005-09-29 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077309-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2005-09-29 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077309-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2005-09-29 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077309-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2005-09-29 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077309-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2005-09-29 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077309-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2005-09-29 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077309-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2005-09-29 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077309-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2005-09-29 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A077309-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2005-09-29 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A077309-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2005-09-29 | 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 | A077309-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077309-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077309-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077309-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077309-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077309-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077309-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077309-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077309-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077309-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077309-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077309-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077309-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077309-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077309-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077309-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077309-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077309-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077309-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077309-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077309-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077309-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077309-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077309-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077309-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077309-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077309-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A077309-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077309-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077309-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077309-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077309-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077309-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A077309-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077309-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077309-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077309-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A077309-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A077309-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A077309-002 | 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 |
|---|---|---|---|---|---|---|
| acyclovir | ACYCLOVIR | REMEDYREPACK INC. | 499c6a98-0614-4ded-8526-909942bae8a4 | 2026-06-26 | Warnings, Adverse reactions | 077309 ANDA077309 70518-0427 |
| acyclovir | ACYCLOVIR | Bryant Ranch Prepack | db35fce0-d7a3-4589-ba60-d78cdb1119cb | 2026-06-18 | Warnings, Adverse reactions | 077309 ANDA077309 71335-1381 |
| acyclovir | ACYCLOVIR | Apotex Corp. | 7fdeb609-24c4-5024-52c3-6a32bc7f3fcc | 2025-11-20 | Warnings, Adverse reactions | 077309 ANDA077309 60505-5307 60505-5306 |
| acyclovir | ACYCLOVIR | Bryant Ranch Prepack | a7fd298b-3914-4316-8484-2d3ae188221a | 2024-08-12 | Warnings, Adverse reactions | 077309 ANDA077309 |
| acyclovir | ACYCLOVIR | NuCare Pharmaceuticals,Inc. | ada4004a-c10a-6190-e053-2a95a90a5e67 | 2024-07-17 | Warnings, Adverse reactions | 077309 ANDA077309 68071-2247 |
| acyclovir | ACYCLOVIR | NuCare Pharmaceuticals,Inc. | b2ae0432-bd2a-1480-e053-2a95a90a6fc8 | 2024-07-17 | Warnings, Adverse reactions | 077309 ANDA077309 68071-2287 |
| acyclovir | ACYCLOVIR | NuCare Pharmaceuticals,Inc. | 968800dc-9456-a45f-e053-2995a90aa15e | 2024-06-19 | Warnings, Adverse reactions | 077309 ANDA077309 68071-5100 |
| acyclovir | ACYCLOVIR | Bryant Ranch Prepack | bf1b4142-c5f3-4147-8224-bf6344566694 | 2024-05-30 | Warnings, Adverse reactions | 077309 ANDA077309 63629-9174 |
| acyclovir | ACYCLOVIR | Proficient Rx LP | 4c5a75fa-73db-4f48-895f-de1635d33f49 | 2021-01-01 | Warnings, Adverse reactions | 077309 ANDA077309 63187-192 |
| acyclovir | ACYCLOVIR | Asclemed USA, Inc. | e186fdc9-b60e-4280-8d60-36cae9f2838f | 2020-09-25 | Warnings, Adverse reactions | 077309 ANDA077309 |
| acyclovir | ACYCLOVIR | Proficient Rx LP | 51052f0e-1a07-405a-a962-981ce9439e02 | 2020-02-01 | Warnings, Adverse reactions | 077309 ANDA077309 71205-391 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0440-7033 | acyclovir | acyclovir | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 0904-5790 | acyclovir | acyclovir | Major Pharmaceuticals | ANDA | Current |
| 0904-5790 | acyclovir | acyclovir | Major Pharmaceuticals | ANDA | Current |
| 0904-5790 | acyclovir | acyclovir | Major Pharmaceuticals | ANDA | Current |
| 0904-5790 | acyclovir | acyclovir | Major Pharmaceuticals | ANDA | Current |
| 12634-697 | acyclovir | acyclovir | Apotheca Inc. | ANDA | Current |
| 35356-903 | Acyclovir | acyclovir | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-903 | Acyclovir | acyclovir | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-903 | Acyclovir | acyclovir | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-903 | Acyclovir | acyclovir | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 43353-933 | Acyclovir | acyclovir | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 49999-231 | acyclovir | acyclovir | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 50090-0637 | acyclovir | acyclovir | A-S Medication Solutions | ANDA | Current |
| 50090-0637 | acyclovir | acyclovir | A-S Medication Solutions | ANDA | Current |
| 50090-0642 | acyclovir | acyclovir | A-S Medication Solutions | ANDA | Current |
| 50090-0643 | acyclovir | acyclovir | A-S Medication Solutions | ANDA | Current |
| 60429-309 | acyclovir | acyclovir | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-309 | acyclovir | acyclovir | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-309 | acyclovir | acyclovir | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-310 | acyclovir | acyclovir | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-310 | acyclovir | acyclovir | Golden State Medical Supply, Inc. | ANDA | Current |
| 60505-5306 | acyclovir | acyclovir | Apotex Corp. | ANDA | Current |
| 60505-5307 | acyclovir | acyclovir | Apotex Corp. | ANDA | Current |
| 61919-003 | ACYCLOVIR | ACYCLOVIR | DIRECT RX | ANDA | Current |
| 61919-003 | ACYCLOVIR | ACYCLOVIR | DIRECT RX | ANDA | Current |
| 61919-003 | ACYCLOVIR | ACYCLOVIR | DIRECT RX | ANDA | Current |
| 61919-003 | ACYCLOVIR | ACYCLOVIR | DIRECT RX | ANDA | Current |
| 63187-192 | acyclovir | acyclovir | Proficient Rx LP | ANDA | Current |
| 63187-192 | acyclovir | acyclovir | Proficient Rx LP | ANDA | Current |
| 63629-1192 | acyclovir | acyclovir | Bryant Ranch Prepack | ANDA | Current |
| 63629-1193 | acyclovir | acyclovir | Bryant Ranch Prepack | ANDA | Current |
| 63629-9174 | acyclovir | acyclovir | Bryant Ranch Prepack | ANDA | Current |
| 63629-9174 | acyclovir | acyclovir | Bryant Ranch Prepack | ANDA | Current |
| 63629-9174 | acyclovir | acyclovir | Bryant Ranch Prepack | ANDA | Current |
| 67296-1034 | acyclovir | acyclovir | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1034 | acyclovir | acyclovir | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1034 | acyclovir | acyclovir | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1707 | acyclovir | acyclovir | RedPharm Drug | ANDA | Current |
| 67296-1707 | acyclovir | acyclovir | RedPharm Drug | ANDA | Current |
| 68071-2247 | acyclovir | acyclovir | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2247 | acyclovir | acyclovir | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2287 | acyclovir | acyclovir | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2287 | acyclovir | acyclovir | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2287 | acyclovir | acyclovir | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5094 | acyclovir | acyclovir | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5094 | acyclovir | acyclovir | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5100 | acyclovir | acyclovir | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5100 | acyclovir | acyclovir | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68084-108 | Acyclovir | Acyclovir | American Health Packaging | ANDA | Current |
| 68084-108 | Acyclovir | Acyclovir | American Health Packaging | ANDA | Current |
| 68084-108 | Acyclovir | Acyclovir | American Health Packaging | ANDA | Current |
| 68084-109 | Acyclovir | Acyclovir | American Health Packaging | ANDA | Current |
| 68084-109 | Acyclovir | Acyclovir | American Health Packaging | ANDA | Current |
| 68084-109 | Acyclovir | Acyclovir | American Health Packaging | ANDA | Current |
| 68788-6360 | acyclovir | acyclovir | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7760 | acyclovir | acyclovir | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7760 | acyclovir | acyclovir | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7760 | acyclovir | acyclovir | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7760 | acyclovir | acyclovir | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7895 | acyclovir | acyclovir | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7895 | acyclovir | acyclovir | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8989 | acyclovir | acyclovir | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-0427 | acyclovir | acyclovir | REMEDYREPACK INC. | ANDA | Current |
| 70518-0427 | acyclovir | acyclovir | REMEDYREPACK INC. | ANDA | Current |
| 70518-0427 | acyclovir | acyclovir | REMEDYREPACK INC. | ANDA | Current |
| 70518-0427 | acyclovir | acyclovir | REMEDYREPACK INC. | ANDA | Current |
| 70518-0427 | acyclovir | acyclovir | REMEDYREPACK INC. | ANDA | Current |
| 70518-0427 | acyclovir | acyclovir | REMEDYREPACK INC. | ANDA | Current |
| 70934-556 | acyclovir | acyclovir | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-556 | acyclovir | acyclovir | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-556 | acyclovir | acyclovir | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-556 | acyclovir | acyclovir | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-557 | acyclovir | acyclovir | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-557 | acyclovir | acyclovir | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-557 | acyclovir | acyclovir | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-694 | acyclovir | acyclovir | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-694 | acyclovir | acyclovir | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-697 | acyclovir | acyclovir | Apotex Corp. | ANDA | Current |
| 71205-391 | acyclovir | acyclovir | Proficient Rx LP | ANDA | Current |
| 71335-1381 | acyclovir | acyclovir | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9035 | ORIG | 2005-10-20 |