Application 060075
- Type
- ANDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PFIZERPEN G | PENICILLIN G POTASSIUM | TABLET;ORAL | 50,000 UNITS | No | No |
| 002 | PFIZERPEN G | PENICILLIN G POTASSIUM | TABLET;ORAL | 100,000 UNITS | No | No |
| 003 | PFIZERPEN G | PENICILLIN G POTASSIUM | TABLET;ORAL | 200,000 UNITS | No | No |
| 004 | PFIZERPEN G | PENICILLIN G POTASSIUM | TABLET;ORAL | 250,000 UNITS | No | No |
| 005 | PFIZERPEN G | PENICILLIN G POTASSIUM | TABLET;ORAL | 400,000 UNITS | No | No |
| 006 | PFIZERPEN G | 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 |
|---|---|---|---|---|---|---|---|
| A060075-001 | PFIZERPEN G | PENICILLIN G POTASSIUM | 50,000 UNITS | TABLET / ORAL | Approved before 1982 | ||
| A060075-002 | PFIZERPEN G | PENICILLIN G POTASSIUM | 100,000 UNITS | TABLET / ORAL | Approved before 1982 | ||
| A060075-003 | PFIZERPEN G | PENICILLIN G POTASSIUM | 200,000 UNITS | TABLET / ORAL | Approved before 1982 | ||
| A060075-004 | PFIZERPEN G | PENICILLIN G POTASSIUM | 250,000 UNITS | TABLET / ORAL | Approved before 1982 | ||
| A060075-005 | PFIZERPEN G | PENICILLIN G POTASSIUM | 400,000 UNITS | TABLET / ORAL | Approved before 1982 | ||
| A060075-006 | PFIZERPEN G | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A060075-005 | PFIZERPEN G | 400,000 UNITS | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A060075-006 | PFIZERPEN G | 800,000 UNITS | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A060075-001 | PFIZERPEN G | 50,000 UNITS | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A060075-002 | PFIZERPEN G | 100,000 UNITS | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A060075-003 | PFIZERPEN G | 200,000 UNITS | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A060075-004 | PFIZERPEN G | 250,000 UNITS | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A060075-005 | PFIZERPEN G | 400,000 UNITS | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A060075-006 | PFIZERPEN G | 800,000 UNITS | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A060075-001 | PFIZERPEN G | 50,000 UNITS | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A060075-002 | PFIZERPEN G | 100,000 UNITS | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A060075-003 | PFIZERPEN G | 200,000 UNITS | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A060075-004 | PFIZERPEN G | 250,000 UNITS | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A060075-005 | PFIZERPEN G | 400,000 UNITS | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A060075-006 | PFIZERPEN G | 800,000 UNITS | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A060075-001 | PFIZERPEN G | 50,000 UNITS | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A060075-002 | PFIZERPEN G | 100,000 UNITS | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A060075-003 | PFIZERPEN G | 200,000 UNITS | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A060075-004 | PFIZERPEN G | 250,000 UNITS | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A060075-005 | PFIZERPEN G | 400,000 UNITS | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A060075-006 | PFIZERPEN G | 800,000 UNITS | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A060075-001 | PFIZERPEN G | 50,000 UNITS | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A060075-002 | PFIZERPEN G | 100,000 UNITS | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A060075-003 | PFIZERPEN G | 200,000 UNITS | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A060075-004 | PFIZERPEN G | 250,000 UNITS | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A060075-005 | PFIZERPEN G | 400,000 UNITS | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A060075-006 | PFIZERPEN G | 800,000 UNITS | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A060075-001 | PFIZERPEN G | 50,000 UNITS | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A060075-002 | PFIZERPEN G | 100,000 UNITS | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A060075-003 | PFIZERPEN G | 200,000 UNITS | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A060075-004 | PFIZERPEN G | 250,000 UNITS | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A060075-005 | PFIZERPEN G | 400,000 UNITS | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A060075-006 | PFIZERPEN G | 800,000 UNITS | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A060075-001 | PFIZERPEN G | 50,000 UNITS | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A060075-002 | PFIZERPEN G | 100,000 UNITS | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A060075-003 | PFIZERPEN G | 200,000 UNITS | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A060075-004 | PFIZERPEN G | 250,000 UNITS | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A060075-005 | PFIZERPEN G | 400,000 UNITS | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A060075-006 | PFIZERPEN G | 800,000 UNITS | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A060075-001 | PFIZERPEN G | 50,000 UNITS | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A060075-002 | PFIZERPEN G | 100,000 UNITS | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… |
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.