Application 079247
- Type
- ANDA
- Sponsor
- NOVEL LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | TABLET;ORAL | 0.398GM;1.102GM | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A079247-001 | MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 0.398GM;1.102GM | TABLET / ORAL | RS | 2011-12-30 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | A079247-001 | MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE | 0.398GM;1.102GM | TABLET / ORAL | AB | 2011-12-30 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A079247-001 | MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE | 0.398GM;1.102GM | TABLET / ORAL | AB | 2011-12-30 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A079247-001 | MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE | 0.398GM;1.102GM | TABLET / ORAL | AB | 2011-12-30 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A079247-001 | MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE | 0.398GM;1.102GM | TABLET / ORAL | RS | 2011-12-30 | a50c72e98297… |
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 | A079247-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A079247-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A079247-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A079247-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A079247-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A079247-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A079247-001 | AB | 1 | 5aa47cf7b7d7… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A079247-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A079247-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A079247-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A079247-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A079247-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A079247-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A079247-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A079247-001 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Monobasic Sodium Phosphate and Dibasic Sodium Phosphate | MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE | Lupin Pharmaceuticals,Inc. | e2fcc382-6fac-4438-ad02-ebc8528dd59a | 2024-01-30 | Boxed warning, Warnings, Adverse reactions | 079247 ANDA079247 43386-030 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 40032-030 | Monobasic Sodium Phosphate and Dibasic Sodium Phosphate | Monobasic Sodium Phosphate and Dibasic Sodium Phosphate | Novel Laboratories, Inc. | ANDA | Current |
| 43386-030 | Monobasic Sodium Phosphate and Dibasic Sodium Phosphate | Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets | Lupin Pharmaceuticals,Inc. | ANDA | Current |