Application 061815
- Type
- ANDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PFIZERPEN VK | PENICILLIN V POTASSIUM | FOR SOLUTION;ORAL | EQ 125MG BASE/5ML | No | No |
| 002 | PFIZERPEN VK | PENICILLIN V POTASSIUM | FOR SOLUTION;ORAL | EQ 250MG BASE/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A061815-001 | PFIZERPEN VK | PENICILLIN V POTASSIUM | EQ 125MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | ||
| A061815-002 | PFIZERPEN VK | PENICILLIN V POTASSIUM | EQ 250MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 |
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 | A061815-001 | PFIZERPEN VK | EQ 125MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A061815-002 | PFIZERPEN VK | EQ 250MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A061815-001 | PFIZERPEN VK | EQ 125MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A061815-002 | PFIZERPEN VK | EQ 250MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061815-001 | PFIZERPEN VK | EQ 125MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061815-002 | PFIZERPEN VK | EQ 250MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A061815-001 | PFIZERPEN VK | EQ 125MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A061815-002 | PFIZERPEN VK | EQ 250MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061815-001 | PFIZERPEN VK | EQ 125MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061815-002 | PFIZERPEN VK | EQ 250MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061815-001 | PFIZERPEN VK | EQ 125MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061815-002 | PFIZERPEN VK | EQ 250MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061815-001 | PFIZERPEN VK | EQ 125MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061815-002 | PFIZERPEN VK | EQ 250MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A061815-001 | PFIZERPEN VK | EQ 125MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A061815-002 | PFIZERPEN VK | EQ 250MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061815-001 | PFIZERPEN VK | EQ 125MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061815-002 | PFIZERPEN VK | EQ 250MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A061815-001 | PFIZERPEN VK | EQ 125MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A061815-002 | PFIZERPEN VK | EQ 250MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A061815-001 | PFIZERPEN VK | EQ 125MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A061815-002 | PFIZERPEN VK | EQ 250MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A061815-001 | PFIZERPEN VK | EQ 125MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A061815-002 | PFIZERPEN VK | EQ 250MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A061815-001 | PFIZERPEN VK | EQ 125MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A061815-002 | PFIZERPEN VK | EQ 250MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A061815-001 | PFIZERPEN VK | EQ 125MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A061815-002 | PFIZERPEN VK | EQ 250MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A061815-001 | PFIZERPEN VK | EQ 125MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A061815-002 | PFIZERPEN VK | EQ 250MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A061815-001 | PFIZERPEN VK | EQ 125MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A061815-002 | PFIZERPEN VK | EQ 250MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A061815-001 | PFIZERPEN VK | EQ 125MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A061815-002 | PFIZERPEN VK | EQ 250MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A061815-001 | PFIZERPEN VK | EQ 125MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A061815-002 | PFIZERPEN VK | EQ 250MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A061815-001 | PFIZERPEN VK | EQ 125MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A061815-002 | PFIZERPEN VK | EQ 250MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A061815-001 | PFIZERPEN VK | EQ 125MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A061815-002 | PFIZERPEN VK | EQ 250MG BASE/5ML | FOR SOLUTION / ORAL | Approved before 1982 | bb7c543d1eb4… |
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 |
|---|---|---|---|---|---|---|
| Penicillin V Potassium | PENICILLIN V POTASSIUM | PD-Rx Pharmaceuticals, Inc. | a251a769-280e-4024-ad7a-317746325818 | 2025-10-09 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | PD-Rx Pharmaceuticals, Inc. | 73cd20d5-2521-4b93-a221-fa3fe490eba6 | 2025-10-08 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | REMEDYREPACK INC. | dd8a48b2-9ff1-49de-a53e-db4964c2384c | 2025-10-02 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | Bryant Ranch Prepack | bdffe8fe-e6e0-4c08-894c-0653605ff433 | 2025-09-26 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | Bryant Ranch Prepack | dde7b33e-84fc-41c9-97f8-10308841200d | 2025-07-10 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | NuCare Pharmaceuticals, Inc. | 4af2a165-0b7d-2539-e054-00144ff8d46c | 2025-06-27 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | NuCare Pharmaceuticals,Inc. | 1c49ef5c-75bb-f9d4-e063-6394a90a951a | 2025-04-23 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | PD-Rx Pharmaceuticals, Inc. | 8d98ea77-f237-4b93-87fa-41f556436ab5 | 2025-04-18 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | PD-Rx Pharmaceuticals, Inc. | 7aef4c8b-aee7-453d-bb6f-fce8e4588e3b | 2025-03-13 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | NuCare Pharmaceuticals,Inc. | 946dbeaa-17ec-4049-e053-2995a90a1462 | 2025-03-05 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | NuCare Pharmaceuticals,Inc. | fbd3f219-d052-fd00-e053-6294a90a66ac | 2025-02-04 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | NuCare Pharmaceuticals,Inc. | fd784ff4-86ec-9ea4-e053-6394a90a8969 | 2025-02-04 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | PD-Rx Pharmaceuticals, Inc. | f3f5947d-0dd3-4b50-93a2-bc8325180978 | 2025-01-20 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | NuCare Pharmaceuticals,Inc. | 55a44735-6d6e-3012-e054-00144ff8d46c | 2024-12-31 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | NuCare Pharmaceuticals,Inc. | 65e59e7a-0ec6-2a76-e053-2991aa0a0021 | 2024-12-06 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | A-S Medication Solutions | 93c1177c-35da-464b-be90-bb18fe9bd27d | 2024-10-24 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | A-S Medication Solutions | 887a719a-4e5f-4e04-9935-7ad7ce75cabe | 2024-07-30 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | NuCare Pharmaceuticals,Inc. | ada3be87-2cdb-75f7-e053-2995a90aa95b | 2024-07-17 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | NuCare Pharmaceuticals,Inc. | 6315850e-f843-a114-e053-2a91aa0a4016 | 2024-07-09 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | Hikma Pharmaceuticals USA Inc. | dc33f7a4-348b-4b4c-a5f2-c4f908fda4aa | 2024-06-25 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |