Application 060003
- Type
- ANDA
- Sponsor
- LILLY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | V-CILLIN K | PENICILLIN V POTASSIUM | TABLET;ORAL | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 002 | V-CILLIN K | PENICILLIN V POTASSIUM | TABLET;ORAL | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 003 | V-CILLIN K | PENICILLIN V POTASSIUM | TABLET;ORAL | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A060003-001 | V-CILLIN K | PENICILLIN V POTASSIUM | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | ||
| A060003-002 | V-CILLIN K | PENICILLIN V POTASSIUM | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | ||
| A060003-003 | V-CILLIN K | PENICILLIN V POTASSIUM | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A060003-001 | V-CILLIN K | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A060003-002 | V-CILLIN K | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A060003-003 | V-CILLIN K | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A060003-001 | V-CILLIN K | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A060003-002 | V-CILLIN K | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A060003-003 | V-CILLIN K | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A060003-001 | V-CILLIN K | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A060003-002 | V-CILLIN K | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A060003-003 | V-CILLIN K | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A060003-001 | V-CILLIN K | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A060003-002 | V-CILLIN K | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A060003-003 | V-CILLIN K | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A060003-001 | V-CILLIN K | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A060003-002 | V-CILLIN K | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A060003-003 | V-CILLIN K | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A060003-001 | V-CILLIN K | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A060003-002 | V-CILLIN K | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A060003-003 | V-CILLIN K | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A060003-001 | V-CILLIN K | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A060003-002 | V-CILLIN K | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A060003-003 | V-CILLIN K | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A060003-001 | V-CILLIN K | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A060003-002 | V-CILLIN K | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A060003-003 | V-CILLIN K | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A060003-001 | V-CILLIN K | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A060003-002 | V-CILLIN K | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A060003-003 | V-CILLIN K | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A060003-001 | V-CILLIN K | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A060003-002 | V-CILLIN K | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A060003-003 | V-CILLIN K | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A060003-001 | V-CILLIN K | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A060003-002 | V-CILLIN K | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A060003-003 | V-CILLIN K | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A060003-001 | V-CILLIN K | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A060003-002 | V-CILLIN K | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A060003-003 | V-CILLIN K | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A060003-001 | V-CILLIN K | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A060003-002 | V-CILLIN K | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A060003-003 | V-CILLIN K | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A060003-001 | V-CILLIN K | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | Approved before 1982 | 8072bd15b7f6… |
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 | REMEDYREPACK INC. | fba1ffe5-809a-495b-bf3e-f2099ac459f6 | 2026-07-28 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | REMEDYREPACK INC. | 8f9fa2c8-4d25-48a8-9257-43c33d08e83a | 2026-07-28 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | REMEDYREPACK INC. | b5972712-f735-46ed-a94a-b84668bb6a82 | 2026-07-24 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | Chartwell RX, LLC | b0744674-ddf7-4022-be2f-2a22bef0d379 | 2026-07-23 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | Redpharm Drug | 546c367a-c786-8326-e063-6294a90ae76c | 2026-07-14 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | Proficient Rx LP | b8f797fb-979c-4eab-a3a6-ad4edcb9ff07 | 2026-06-01 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | REMEDYREPACK INC. | 5f0759cc-c553-49b9-9049-80e713758958 | 2026-04-09 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | Bryant Ranch Prepack | 609c3e26-9220-4f3c-b393-a2b41b68de6c | 2026-03-12 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | QPharma Inc | 8c11af69-146f-47ed-b12a-7b201fec7e50 | 2025-12-04 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | PD-Rx Pharmaceuticals, Inc. | ceddc406-4a17-471f-917e-63b4b03779ea | 2025-10-17 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | PD-Rx Pharmaceuticals, Inc. | 9bc7006d-a482-47c4-a138-5380ce927812 | 2025-10-16 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | PD-Rx Pharmaceuticals, Inc. | 4ad879d4-eb32-49f0-af73-c47fc7581936 | 2025-10-15 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | PD-Rx Pharmaceuticals, Inc. | 450ad3aa-7c9e-497b-b00e-b1af0322f8d0 | 2025-10-15 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | PD-Rx Pharmaceuticals, Inc. | 0151c742-7525-4707-af03-bd48d50cd586 | 2025-10-15 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | PD-Rx Pharmaceuticals, Inc. | 281f9c32-e28a-46ae-9e4e-c2143aaa6c6b | 2025-10-15 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| Penicillin V Potassium | PENICILLIN V POTASSIUM | PD-Rx Pharmaceuticals, Inc. | aa90bf0b-c08d-43e5-b247-1a5c5e3c94e4 | 2025-10-15 | Warnings, Adverse reactions | PENICILLIN V POTASSIUM |
| 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 |