Application 062155
- Type
- ANDA
- Sponsor
- APOTHECON
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PENTIDS '200' | PENICILLIN G POTASSIUM | TABLET;ORAL | 200,000 UNITS | No | No |
| 002 | PENTIDS '250' | PENICILLIN G POTASSIUM | TABLET;ORAL | 250,000 UNITS | No | No |
| 003 | PENTIDS '400' | PENICILLIN G POTASSIUM | TABLET;ORAL | 400,000 UNITS | No | No |
| 004 | PENTIDS '800' | PENICILLIN G POTASSIUM | TABLET;ORAL | 800,000 UNITS | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062155-001 | PENTIDS '200' | PENICILLIN G POTASSIUM | 200,000 UNITS | TABLET / ORAL | Approved before 1982 | ||
| A062155-002 | PENTIDS '250' | PENICILLIN G POTASSIUM | 250,000 UNITS | TABLET / ORAL | Approved before 1982 | ||
| A062155-003 | PENTIDS '400' | PENICILLIN G POTASSIUM | 400,000 UNITS | TABLET / ORAL | Approved before 1982 | ||
| A062155-004 | PENTIDS '800' | PENICILLIN G POTASSIUM | 800,000 UNITS | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A062155-001 | PENTIDS '200' | 200,000 UNITS | TABLET / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062155-002 | PENTIDS '250' | 250,000 UNITS | TABLET / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062155-003 | PENTIDS '400' | 400,000 UNITS | TABLET / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062155-004 | PENTIDS '800' | 800,000 UNITS | TABLET / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062155-001 | PENTIDS '200' | 200,000 UNITS | TABLET / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062155-002 | PENTIDS '250' | 250,000 UNITS | TABLET / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062155-003 | PENTIDS '400' | 400,000 UNITS | TABLET / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062155-004 | PENTIDS '800' | 800,000 UNITS | TABLET / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062155-001 | PENTIDS '200' | 200,000 UNITS | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062155-002 | PENTIDS '250' | 250,000 UNITS | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062155-003 | PENTIDS '400' | 400,000 UNITS | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062155-004 | PENTIDS '800' | 800,000 UNITS | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062155-001 | PENTIDS '200' | 200,000 UNITS | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062155-002 | PENTIDS '250' | 250,000 UNITS | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062155-003 | PENTIDS '400' | 400,000 UNITS | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062155-004 | PENTIDS '800' | 800,000 UNITS | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062155-001 | PENTIDS '200' | 200,000 UNITS | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062155-002 | PENTIDS '250' | 250,000 UNITS | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062155-003 | PENTIDS '400' | 400,000 UNITS | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062155-004 | PENTIDS '800' | 800,000 UNITS | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062155-001 | PENTIDS '200' | 200,000 UNITS | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062155-002 | PENTIDS '250' | 250,000 UNITS | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062155-003 | PENTIDS '400' | 400,000 UNITS | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062155-004 | PENTIDS '800' | 800,000 UNITS | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062155-001 | PENTIDS '200' | 200,000 UNITS | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062155-002 | PENTIDS '250' | 250,000 UNITS | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062155-003 | PENTIDS '400' | 400,000 UNITS | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062155-004 | PENTIDS '800' | 800,000 UNITS | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062155-001 | PENTIDS '200' | 200,000 UNITS | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062155-002 | PENTIDS '250' | 250,000 UNITS | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062155-003 | PENTIDS '400' | 400,000 UNITS | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062155-004 | PENTIDS '800' | 800,000 UNITS | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062155-001 | PENTIDS '200' | 200,000 UNITS | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062155-002 | PENTIDS '250' | 250,000 UNITS | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062155-003 | PENTIDS '400' | 400,000 UNITS | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062155-004 | PENTIDS '800' | 800,000 UNITS | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062155-001 | PENTIDS '200' | 200,000 UNITS | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062155-002 | PENTIDS '250' | 250,000 UNITS | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062155-003 | PENTIDS '400' | 400,000 UNITS | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062155-004 | PENTIDS '800' | 800,000 UNITS | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… |
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 G POTASSIUM | PENICILLIN G POTASSIUM | HF Acquisition Co LLC, DBA HealthFirst | 56ab659e-ad28-028f-e063-6394a90a6943 | 2026-07-15 | Warnings, Adverse reactions | PENICILLIN G POTASSIUM |
| PENICILLIN G POTASSIUM | PENICILLIN G POTASSIUM | HF Acquisition Co LLC, DBA HealthFirst | 50c7500f-be06-01af-e063-6294a90a0135 | 2026-05-01 | Warnings, Adverse reactions | PENICILLIN G POTASSIUM |
| Pfizerpen | PENICILLIN G POTASSIUM | Roerig | efef4846-9497-41af-8dd6-518f86eca7f2 | 2025-12-16 | Warnings, Adverse reactions | PENICILLIN G POTASSIUM |
| Penicillin G Potassium | PENICILLIN G POTASSIUM | Avenacy Inc. | 969a421e-37d8-499e-9e89-67e210bd5d9d | 2025-02-01 | Warnings, Adverse reactions | PENICILLIN G POTASSIUM |
| Penicillin G Potassium | PENICILLIN G POTASSIUM | Athenex Pharmaceutical Division, LLC. | 1442486a-05d6-4dce-8b95-857a30f478c2 | 2025-01-28 | Warnings, Adverse reactions | PENICILLIN G POTASSIUM |
| Pfizerpen | PENICILLIN G POTASSIUM | Roerig | 2f7ea103-56cc-492f-b862-af45f9aed980 | 2024-12-12 | Warnings, Adverse reactions | PENICILLIN G POTASSIUM |
| Pfizerpen | PENICILLIN G POTASSIUM | Roerig | d8aaefb6-3f7d-4bc5-b40a-1c58c3054320 | 2024-12-10 | Warnings, Adverse reactions | PENICILLIN G POTASSIUM |
| Penicillin G Potassium | PENICILLIN G POTASSIUM | Sagent Pharmaceuticals | fb2f3afe-0072-4383-bad8-9da9e94db4f2 | 2024-12-04 | Warnings, Adverse reactions | PENICILLIN G POTASSIUM |
| Penicillin G Potassium | PENICILLIN G POTASSIUM | NorthStar Rx, LLC | 8732b7ff-2e47-4f99-aadf-81861b431f4f | 2024-06-28 | Warnings, Adverse reactions | PENICILLIN G POTASSIUM |
| Penicillin G Potassium | PENICILLIN G POTASSIUM | Sandoz Inc | 91950983-4884-40d1-abd8-bcc953d61b7f | 2020-09-16 | Warnings, Adverse reactions | PENICILLIN G POTASSIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.