Application 040185
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | TABLET;ORAL | EQ 10MG BASE | No | No |
| 002 | PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | TABLET;ORAL | EQ 5MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040185-001 | PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | 1996-10-28 | ||
| A040185-002 | PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | 1996-10-28 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040185-001 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | 1996-10-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040185-002 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | 1996-10-28 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040185-001 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | 1996-10-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040185-002 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | 1996-10-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040185-001 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | 1996-10-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040185-002 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | 1996-10-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040185-001 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | 1996-10-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040185-002 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | 1996-10-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040185-001 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | 1996-10-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040185-002 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | 1996-10-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040185-001 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | 1996-10-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040185-002 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | 1996-10-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040185-001 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | 1996-10-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040185-002 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | 1996-10-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040185-001 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | 1996-10-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040185-002 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | 1996-10-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040185-001 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | 1996-10-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040185-002 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | 1996-10-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040185-001 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | 1996-10-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040185-002 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | 1996-10-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040185-001 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | 1996-10-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040185-002 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | 1996-10-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040185-001 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | 1996-10-28 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040185-002 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | 1996-10-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040185-001 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | 1996-10-28 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040185-002 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | 1996-10-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040185-001 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | 1996-10-28 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040185-002 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | 1996-10-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A040185-001 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | 1996-10-28 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A040185-002 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | 1996-10-28 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040185-001 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | AB | 1996-10-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040185-002 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | AB | 1996-10-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040185-001 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | AB | 1996-10-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040185-002 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | AB | 1996-10-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040185-001 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | AB | 1996-10-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040185-002 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | AB | 1996-10-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040185-001 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | AB | 1996-10-28 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040185-002 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | AB | 1996-10-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A040185-001 | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET / ORAL | AB | 1996-10-28 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A040185-002 | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET / ORAL | AB | 1996-10-28 | bb7c543d1eb4… |
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 | A040185-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040185-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040185-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040185-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040185-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040185-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040185-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040185-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040185-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040185-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040185-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A040185-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040185-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040185-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040185-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A040185-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040185-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A040185-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040185-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A040185-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A040185-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A040185-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A040185-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A040185-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040185-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A040185-002 | AB | 1 | ea99ee380514… |
| 2022-09-29 23:25 UTC | 2022-09 | A040185-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A040185-002 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A040185-001 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A040185-002 | AB | 1 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|
| 0378-5105 | Prochlorperazine Maleate | prochlorperazine maleate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5105 | Prochlorperazine Maleate | prochlorperazine maleate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5110 | Prochlorperazine Maleate | prochlorperazine maleate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5110 | Prochlorperazine Maleate | prochlorperazine maleate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0615-2519 | Prochlorperazine Maleate | prochlorperazine maleate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-2520 | Prochlorperazine Maleate | prochlorperazine maleate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 35356-672 | Prochlorperazine Maleate | prochlorperazine maleate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 43063-160 | Prochlorperazine Maleate | prochlorperazine maleate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-353 | Prochlorperazine Maleate | prochlorperazine maleate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-353 | Prochlorperazine Maleate | prochlorperazine maleate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-353 | Prochlorperazine Maleate | prochlorperazine maleate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-607 | Prochlorperazine Maleate | prochlorperazine maleate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-0110 | Prochlorperazine Maleate | prochlorperazine maleate | A-S Medication Solutions | ANDA | Current |
| 50090-0110 | Prochlorperazine Maleate | prochlorperazine maleate | A-S Medication Solutions | ANDA | Current |
| 50090-0111 | Prochlorperazine Maleate | prochlorperazine maleate | A-S Medication Solutions | ANDA | Current |
| 50090-1854 | Prochlorperazine Maleate | prochlorperazine maleate | A-S Medication Solutions | ANDA | Current |
| 50090-1854 | Prochlorperazine Maleate | prochlorperazine maleate | A-S Medication Solutions | ANDA | Current |
| 51079-541 | Prochlorperazine Maleate | prochlorperazine maleate | Mylan Institutional Inc. | ANDA | Current |
| 51079-541 | Prochlorperazine Maleate | prochlorperazine maleate | Mylan Institutional Inc. | ANDA | Current |
| 51079-542 | Prochlorperazine Maleate | prochlorperazine maleate | Mylan Institutional Inc. | ANDA | Current |
| 51079-542 | Prochlorperazine Maleate | prochlorperazine maleate | Mylan Institutional Inc. | ANDA | Current |
| 55154-5094 | Prochlorperazine Maleate | prochlorperazine maleate | Cardinal Health | ANDA | Current |
| 55154-5094 | Prochlorperazine Maleate | prochlorperazine maleate | Cardinal Health | ANDA | Current |
| 55289-224 | Prochlorperazine Maleate | prochlorperazine maleate | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 55289-224 | Prochlorperazine Maleate | prochlorperazine maleate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-224 | Prochlorperazine Maleate | prochlorperazine maleate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-224 | Prochlorperazine Maleate | prochlorperazine maleate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-568 | Prochlorperazine Maleate | prochlorperazine maleate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 61919-653 | Prochlorperazine Maleate | Prochlorperazine Maleate | Direct_Rx | ANDA | Current |
| 67296-0027 | Prochlorperazine Maleate | prochlorperazine maleate | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1405 | Prochlorperazine Maleate | Prochlorperazine Maleate | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1405 | Prochlorperazine Maleate | Prochlorperazine Maleate | RedPharm Drug, Inc. | ANDA | Current |
| 70518-0768 | Prochlorperazine Maleate | prochlorperazine maleate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0768 | Prochlorperazine Maleate | prochlorperazine maleate | REMEDYREPACK INC. | ANDA | Current |
| 71335-0543 | Prochlorperazine Maleate | prochlorperazine maleate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0543 | Prochlorperazine Maleate | prochlorperazine maleate | Bryant Ranch Prepack | ANDA | Current |