Application 064071
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PENICILLIN V POTASSIUM | PENICILLIN V POTASSIUM | TABLET;ORAL | EQ 250MG BASE | No | No |
| 002 | PENICILLIN V POTASSIUM | PENICILLIN V POTASSIUM | TABLET;ORAL | EQ 500MG BASE | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A064071-001 | PENICILLIN V POTASSIUM | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET / ORAL | 1995-11-30 | ||
| A064071-002 | PENICILLIN V POTASSIUM | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET / ORAL | 1995-11-30 |
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 | A064071-001 | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET / ORAL | 1995-11-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A064071-002 | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET / ORAL | 1995-11-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064071-001 | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET / ORAL | 1995-11-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064071-002 | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET / ORAL | 1995-11-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A064071-001 | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET / ORAL | 1995-11-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A064071-002 | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET / ORAL | 1995-11-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064071-001 | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET / ORAL | 1995-11-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064071-002 | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET / ORAL | 1995-11-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064071-001 | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET / ORAL | 1995-11-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064071-002 | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET / ORAL | 1995-11-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064071-001 | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET / ORAL | 1995-11-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064071-002 | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET / ORAL | 1995-11-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064071-001 | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET / ORAL | 1995-11-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064071-002 | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET / ORAL | 1995-11-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064071-001 | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET / ORAL | 1995-11-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064071-002 | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET / ORAL | 1995-11-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064071-001 | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET / ORAL | 1995-11-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064071-002 | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET / ORAL | 1995-11-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A064071-001 | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET / ORAL | 1995-11-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A064071-002 | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET / ORAL | 1995-11-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064071-001 | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET / ORAL | 1995-11-30 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064071-002 | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET / ORAL | 1995-11-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064071-001 | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET / ORAL | 1995-11-30 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064071-002 | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET / ORAL | 1995-11-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064071-001 | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET / ORAL | 1995-11-30 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064071-002 | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET / ORAL | 1995-11-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A064071-001 | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET / ORAL | 1995-11-30 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A064071-002 | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET / ORAL | 1995-11-30 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064071-001 | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET / ORAL | AB | 1995-11-30 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064071-002 | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET / ORAL | AB | RS | 1995-11-30 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A064071-001 | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET / ORAL | AB | 1995-11-30 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A064071-002 | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET / ORAL | AB | RS | 1995-11-30 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A064071-001 | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET / ORAL | AB | 1995-11-30 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A064071-002 | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET / ORAL | AB | RS | 1995-11-30 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A064071-001 | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET / ORAL | AB | 1995-11-30 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A064071-002 | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET / ORAL | AB | RS | 1995-11-30 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A064071-001 | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET / ORAL | AB | 1995-11-30 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A064071-002 | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET / ORAL | AB | RS | 1995-11-30 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A064071-001 | PENICILLIN V POTASSIUM | EQ 250MG BASE | TABLET / ORAL | AB | 1995-11-30 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A064071-002 | PENICILLIN V POTASSIUM | EQ 500MG BASE | TABLET / ORAL | AB | RS | 1995-11-30 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064071-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064071-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A064071-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A064071-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A064071-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A064071-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A064071-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A064071-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A064071-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A064071-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A064071-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A064071-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A064071-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A064071-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A064071-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A064071-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A064071-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A064071-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A064071-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A064071-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A064071-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A064071-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A064071-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A064071-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A064071-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A064071-002 | AB | 1 | ea99ee380514… |
| 2023-12-20 04:57 UTC | 2023-12 | A064071-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A064071-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A064071-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A064071-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A064071-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A064071-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A064071-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A064071-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A064071-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A064071-002 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A064071-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A064071-002 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A064071-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A064071-002 | AB | 1 | 3bdfa0b2c4d7… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-1205 | Penicillin V Potasium | Penicillin V Potasium | Sandoz Inc | ANDA | Current |
| 0781-1205 | Penicillin V Potasium | Penicillin V Potasium | Sandoz Inc | ANDA | Current |
| 0781-1205 | Penicillin V Potasium | Penicillin V Potasium | Sandoz Inc | ANDA | Current |
| 0781-1655 | Penicillin V Potasium | Penicillin V Potasium | Sandoz Inc | ANDA | Current |
| 0781-1655 | Penicillin V Potasium | Penicillin V Potasium | Sandoz Inc | ANDA | Current |
| 0781-1655 | Penicillin V Potasium | Penicillin V Potasium | Sandoz Inc | ANDA | Current |
| 10544-975 | Penicillin V Potasium | Penicillin V Potasium | Blenheim Pharmacal, Inc. | ANDA | Current |
| 53217-290 | Penicillin V Potasium | Penicillin V Potasium | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 55700-404 | Penicillin V Potasium | Penicillin V Potasium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 67296-0044 | Penicillin V Potasium | Penicillin V Potasium | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0044 | Penicillin V Potasium | Penicillin V Potasium | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0044 | Penicillin V Potasium | Penicillin V Potasium | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1164 | Penicillin V Potasium | Penicillin V Potasium | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1164 | Penicillin V Potasium | Penicillin V Potasium | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1164 | Penicillin V Potasium | Penicillin V Potasium | RedPharm Drug, Inc. | ANDA | Current |
| 70518-2192 | Penicillin V Potasium | Penicillin V Potasium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2192 | Penicillin V Potasium | Penicillin V Potasium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2192 | Penicillin V Potasium | Penicillin V Potasium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2441 | Penicillin V Potasium | Penicillin V Potasium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2441 | Penicillin V Potasium | Penicillin V Potasium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2482 | Penicillin V Potasium | Penicillin V Potasium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2482 | Penicillin V Potasium | Penicillin V Potasium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2482 | Penicillin V Potasium | Penicillin V Potasium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2529 | Penicillin V Potasium | Penicillin V Potasium | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 18319 | SUPPL | 2014-02-06 |