Application 019909
- Type
- NDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZOVIRAX | ACYCLOVIR | SUSPENSION;ORAL | 200MG/5ML | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019909-001 | ZOVIRAX | ACYCLOVIR | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD | 1989-12-22 |
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| 2026-08 | N019909-001 | ZOVIRAX | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD | 1989-12-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019909-001 | ZOVIRAX | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD | 1989-12-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019909-001 | ZOVIRAX | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD | 1989-12-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019909-001 | ZOVIRAX | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD | 1989-12-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019909-001 | ZOVIRAX | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD | 1989-12-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | RLD | 1989-12-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | RLD | 1989-12-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | RLD | 1989-12-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | RLD | 1989-12-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | RLD | 1989-12-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | RLD | 1989-12-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | RLD | 1989-12-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | RLD | 1989-12-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | RLD | 1989-12-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | RLD | 1989-12-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | RLD | 1989-12-22 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 1989-12-22 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 1989-12-22 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 1989-12-22 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 1989-12-22 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 1989-12-22 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 1989-12-22 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 1989-12-22 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 1989-12-22 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 1989-12-22 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 1989-12-22 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 1989-12-22 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 1989-12-22 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 1989-12-22 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | RLD | 1989-12-22 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | RLD | 1989-12-22 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | RLD | 1989-12-22 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | RLD | 1989-12-22 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | RLD | 1989-12-22 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | RLD | 1989-12-22 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | RLD | 1989-12-22 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 1989-12-22 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 1989-12-22 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 1989-12-22 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N019909-001 | ZOVIRAX | 200MG/5ML | SUSPENSION / ORAL | AB | RLD, RS | 1989-12-22 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019909-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N019909-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N019909-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N019909-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N019909-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N019909-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019909-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N019909-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N019909-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N019909-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N019909-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N019909-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N019909-001 | AB | 1 | ea99ee380514… |
| 2023-05-13 08:27 UTC | 2023-05 | N019909-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N019909-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019909-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N019909-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N019909-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N019909-001 | AB | 1 | cb3db0bc1861… |
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 | A-S Medication Solutions | 6ea3e3f6-132d-4b15-ac58-336de05201a7 | 2024-10-14 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Proficient Rx LP | 290af212-7332-4914-9ef0-65760478fb32 | 2024-10-01 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Golden State Medical Supply, Inc. | 0d99ba77-c3c5-1fd0-e063-6294a90a6f2a | 2024-09-30 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Bryant Ranch Prepack | e0f17e6f-63c7-4828-8585-91fc582df30b | 2024-09-06 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Bryant Ranch Prepack | f09cdb3f-dfd2-4e47-bb5e-a5d26d8bcc89 | 2024-09-06 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Bryant Ranch Prepack | 8c5d1f30-2d31-417d-860b-7228b7baaa64 | 2024-09-06 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Golden State Medical Supply, Inc. | 785d68bc-0bbf-b69d-e053-2991aa0ac0d5 | 2024-09-05 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Bryant Ranch Prepack | af9d41f5-4658-4487-8811-32a1f8af9384 | 2024-09-05 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Bryant Ranch Prepack | 89583890-186b-4a7a-8741-41f6c5f0a99d | 2024-09-05 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Bryant Ranch Prepack | 01ae85df-d1a0-44f7-b4c0-0ac74d2216d4 | 2024-09-05 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Carlsbad Technology, Inc. | a68e610a-841c-4b69-9233-673d060561e8 | 2024-08-26 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Carlsbad Technology, Inc. | 37499620-6a17-40f1-b0db-dd79320ea21d | 2024-08-26 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | NuCare Pharmaceuticals,Inc. | c46d5033-b1b2-e213-e053-2995a90ae6a3 | 2024-08-22 | Warnings, Adverse reactions | ACYCLOVIR |
| acyclovir | ACYCLOVIR | NuCare Pharmaceuticals, Inc. | 40e5cc54-ed74-3369-e054-00144ff88e88 | 2024-08-14 | Warnings, Adverse reactions | ACYCLOVIR |
| Acyclovir | ACYCLOVIR | Zydus Lifesciences Limited | bb956f2b-627a-49bd-b258-4aac21d64b9a | 2024-08-14 | ACYCLOVIR | |
| acyclovir | ACYCLOVIR | Zydus Lifesciences Limited | fdf6b492-a76e-4cea-89a1-a5b19c7938ff | 2024-08-14 | ACYCLOVIR | |
| acyclovir | ACYCLOVIR | Bryant Ranch Prepack | a7fd298b-3914-4316-8484-2d3ae188221a | 2024-08-12 | Warnings, Adverse reactions | ACYCLOVIR |
| acyclovir | ACYCLOVIR | NuCare Pharmaceuticals,Inc. | ada4004a-c10a-6190-e053-2a95a90a5e67 | 2024-07-17 | Warnings, Adverse reactions | ACYCLOVIR |
| ACYCLOVIR | ACYCLOVIR | NuCare Pharmaceuticals,Inc. | b1b999a9-11cc-d6e5-e053-2995a90a5478 | 2024-07-17 | Warnings, Adverse reactions | ACYCLOVIR |
| acyclovir | ACYCLOVIR | NuCare Pharmaceuticals,Inc. | b2ae0432-bd2a-1480-e053-2a95a90a6fc8 | 2024-07-17 | Warnings, Adverse reactions | ACYCLOVIR |
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 |
|---|---|---|---|---|---|
| 0378-8712 | Acyclovir | Acyclovir | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-8712 | Acyclovir | Acyclovir | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-9735 | Zovirax | Acyclovir | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-9735 | Zovirax | Acyclovir | Mylan Pharmaceuticals Inc. | NDA | Current |
| 40076-953 | ZOVIRAX | acyclovir | Prestium Pharma, Inc. | NDA | Current |
| 40085-842 | Acyclovir | Acyclovir | Renaissance Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |