Application 062149
- Type
- ANDA
- Sponsor
- APOTHECON
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PENTIDS '200' | PENICILLIN G POTASSIUM | FOR SOLUTION;ORAL | 200,000 UNITS/5ML | No | No |
| 002 | PENTIDS '400' | PENICILLIN G POTASSIUM | FOR SOLUTION;ORAL | 400,000 UNITS/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062149-001 | PENTIDS '200' | PENICILLIN G POTASSIUM | 200,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | ||
| A062149-002 | PENTIDS '400' | PENICILLIN G POTASSIUM | 400,000 UNITS/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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | A062149-001 | PENTIDS '200' | 200,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A062149-002 | PENTIDS '400' | 400,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A062149-001 | PENTIDS '200' | 200,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A062149-002 | PENTIDS '400' | 400,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062149-001 | PENTIDS '200' | 200,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062149-002 | PENTIDS '400' | 400,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A062149-001 | PENTIDS '200' | 200,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A062149-002 | PENTIDS '400' | 400,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A062149-001 | PENTIDS '200' | 200,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A062149-002 | PENTIDS '400' | 400,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A062149-001 | PENTIDS '200' | 200,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A062149-002 | PENTIDS '400' | 400,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A062149-001 | PENTIDS '200' | 200,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A062149-002 | PENTIDS '400' | 400,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A062149-001 | PENTIDS '200' | 200,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A062149-002 | PENTIDS '400' | 400,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A062149-001 | PENTIDS '200' | 200,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A062149-002 | PENTIDS '400' | 400,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A062149-001 | PENTIDS '200' | 200,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A062149-002 | PENTIDS '400' | 400,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A062149-001 | PENTIDS '200' | 200,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A062149-002 | PENTIDS '400' | 400,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A062149-001 | PENTIDS '200' | 200,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A062149-002 | PENTIDS '400' | 400,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A062149-001 | PENTIDS '200' | 200,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A062149-002 | PENTIDS '400' | 400,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A062149-001 | PENTIDS '200' | 200,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A062149-002 | PENTIDS '400' | 400,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A062149-001 | PENTIDS '200' | 200,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A062149-002 | PENTIDS '400' | 400,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A062149-001 | PENTIDS '200' | 200,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A062149-002 | PENTIDS '400' | 400,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A062149-001 | PENTIDS '200' | 200,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A062149-002 | PENTIDS '400' | 400,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A062149-001 | PENTIDS '200' | 200,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A062149-002 | PENTIDS '400' | 400,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A062149-001 | PENTIDS '200' | 200,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A062149-002 | PENTIDS '400' | 400,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A062149-001 | PENTIDS '200' | 200,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A062149-002 | PENTIDS '400' | 400,000 UNITS/5ML | FOR SOLUTION / ORAL | Approved before 1982 | f41ea6bd6efb… |
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.