Application 040352
- Type
- ANDA
- Sponsor
- SPECGX LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
| 002 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040352-001 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2000-06-13 | ||
| A040352-002 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-06-13 |
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 | A040352-001 | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2000-06-13 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A040352-002 | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-06-13 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A040352-001 | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2000-06-13 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A040352-002 | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-06-13 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040352-001 | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2000-06-13 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040352-002 | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-06-13 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A040352-001 | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2000-06-13 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A040352-002 | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-06-13 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A040352-001 | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2000-06-13 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A040352-002 | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-06-13 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A040352-001 | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2000-06-13 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A040352-002 | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-06-13 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A040352-001 | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2000-06-13 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A040352-002 | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-06-13 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A040352-001 | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2000-06-13 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A040352-002 | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-06-13 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A040352-001 | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2000-06-13 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | A040352-002 | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2000-06-13 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040352-001 | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2000-06-13 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040352-002 | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-06-13 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A040352-001 | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2000-06-13 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A040352-002 | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-06-13 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A040352-001 | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2000-06-13 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A040352-002 | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-06-13 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040352-001 | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2000-06-13 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040352-002 | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-06-13 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040352-001 | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2000-06-13 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040352-002 | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-06-13 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040352-001 | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2000-06-13 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040352-002 | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-06-13 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040352-001 | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2000-06-13 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040352-002 | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-06-13 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A040352-001 | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2000-06-13 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A040352-002 | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-06-13 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A040352-001 | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2000-06-13 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A040352-002 | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-06-13 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040352-001 | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2000-06-13 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040352-002 | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-06-13 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A040352-001 | MEPERIDINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2000-06-13 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A040352-002 | MEPERIDINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2000-06-13 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-07-19 19:46 UTC | 2019-07 | A040352-001 | AA | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A040352-002 | AA | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| DEMEROL | MEPERIDINE HYDROCHLORIDE | Hospira, Inc. | b31d1308-28c3-43f4-e0a6-2f3ed76b8975 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | MEPERIDINE HYDROCHLORIDE |
| Meperidine Hydrochloride | MEPERIDINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 15bc51a8-1e24-4d33-9a2f-05a41c29acf0 | 2026-02-27 | Boxed warning, Warnings, Adverse reactions | Meperidine Hydrochloride MEPERIDINE HYDROCHLORIDE |
| Meperidine Hydrochloride | MEPERIDINE HYDROCHLORIDE | Genus Lifesciences Inc. | 792fefda-6cc4-4709-b902-fd9787fc310a | 2026-02-13 | Boxed warning, Warnings, Adverse reactions | Meperidine Hydrochloride MEPERIDINE HYDROCHLORIDE |
| Meperidine Hydrochloride | MEPERIDINE HYDROCHLORIDE | EPIC PHARMA, LLC | fae5cc34-5917-4445-9516-25f97ffca8db | 2025-11-29 | Boxed warning, Warnings, Adverse reactions | Meperidine Hydrochloride MEPERIDINE HYDROCHLORIDE |
| MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | e0e998da-f056-4fce-be8e-ed60cf3b461b | 2024-04-09 | Boxed warning, Warnings, Adverse reactions | MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.