Application 203158
- Type
- ANDA
- Sponsor
- NORTEC DEV ASSOC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MORPHINE SULFATE | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 20MG | No | No |
| 002 | MORPHINE SULFATE | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 30MG | No | No |
| 003 | MORPHINE SULFATE | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 50MG | No | No |
| 004 | MORPHINE SULFATE | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 60MG | No | No |
| 005 | MORPHINE SULFATE | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 80MG | No | No |
| 006 | MORPHINE SULFATE | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203158-001 | MORPHINE SULFATE | MORPHINE SULFATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | ||
| A203158-002 | MORPHINE SULFATE | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | ||
| A203158-003 | MORPHINE SULFATE | MORPHINE SULFATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | ||
| A203158-004 | MORPHINE SULFATE | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | ||
| A203158-005 | MORPHINE SULFATE | MORPHINE SULFATE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | ||
| A203158-006 | MORPHINE SULFATE | MORPHINE SULFATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 |
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 | A203158-001 | MORPHINE SULFATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A203158-002 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A203158-003 | MORPHINE SULFATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A203158-004 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A203158-005 | MORPHINE SULFATE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A203158-006 | MORPHINE SULFATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203158-001 | MORPHINE SULFATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203158-002 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203158-003 | MORPHINE SULFATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203158-004 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203158-005 | MORPHINE SULFATE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203158-006 | MORPHINE SULFATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203158-001 | MORPHINE SULFATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203158-002 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203158-003 | MORPHINE SULFATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203158-004 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203158-005 | MORPHINE SULFATE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203158-006 | MORPHINE SULFATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203158-001 | MORPHINE SULFATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203158-002 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203158-003 | MORPHINE SULFATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203158-004 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203158-005 | MORPHINE SULFATE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203158-006 | MORPHINE SULFATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203158-001 | MORPHINE SULFATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203158-002 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203158-003 | MORPHINE SULFATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203158-004 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203158-005 | MORPHINE SULFATE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203158-006 | MORPHINE SULFATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203158-001 | MORPHINE SULFATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203158-002 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203158-003 | MORPHINE SULFATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203158-004 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203158-005 | MORPHINE SULFATE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203158-006 | MORPHINE SULFATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203158-001 | MORPHINE SULFATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203158-002 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203158-003 | MORPHINE SULFATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203158-004 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-08-04 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2021-12-28 21:50 UTC | 2021-12 | A203158-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A203158-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A203158-003 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A203158-004 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A203158-005 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A203158-006 | AB | 1 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|---|
| Morphine Sulfate | MORPHINE SULFATE | Nortec Development Associates, Inc. | 9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4 | 2025-08-25 | Boxed warning, Warnings, Adverse reactions | 203158 ANDA203158 42689-009 42689-010 42689-005 42689-007 42689-008 42689-006 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42689-005 | Morphine Sulfate | morphine sulfate | Nortec Development Associates, Inc. | ANDA | Current |
| 42689-006 | Morphine Sulfate | morphine sulfate | Nortec Development Associates, Inc. | ANDA | Current |
| 42689-007 | Morphine Sulfate | morphine sulfate | Nortec Development Associates, Inc. | ANDA | Current |
| 42689-008 | Morphine Sulfate | morphine sulfate | Nortec Development Associates, Inc. | ANDA | Current |
| 42689-009 | Morphine Sulfate | morphine sulfate | Nortec Development Associates, Inc. | ANDA | Current |
| 42689-010 | Morphine Sulfate | morphine sulfate | Nortec Development Associates, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76475 | ORIG | 2023-11-07 |