Application 079040
- Type
- ANDA
- Sponsor
- ACTAVIS ELIZABETH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MORPHINE SULFATE | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 30MG | No | No |
| 002 | MORPHINE SULFATE | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 45MG | No | No |
| 003 | MORPHINE SULFATE | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 60MG | No | No |
| 004 | MORPHINE SULFATE | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 75MG | No | No |
| 005 | MORPHINE SULFATE | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 90MG | No | No |
| 006 | MORPHINE SULFATE | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 120MG | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A079040-001 | MORPHINE SULFATE | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | ||
| A079040-002 | MORPHINE SULFATE | MORPHINE SULFATE | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | ||
| A079040-003 | MORPHINE SULFATE | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | ||
| A079040-004 | MORPHINE SULFATE | MORPHINE SULFATE | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | ||
| A079040-005 | MORPHINE SULFATE | MORPHINE SULFATE | 90MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | ||
| A079040-006 | MORPHINE SULFATE | MORPHINE SULFATE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2013-01-16 |
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 | A079040-001 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079040-002 | MORPHINE SULFATE | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079040-003 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079040-004 | MORPHINE SULFATE | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079040-005 | MORPHINE SULFATE | 90MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079040-006 | MORPHINE SULFATE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2013-01-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079040-001 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079040-002 | MORPHINE SULFATE | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079040-003 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079040-004 | MORPHINE SULFATE | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079040-005 | MORPHINE SULFATE | 90MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079040-006 | MORPHINE SULFATE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2013-01-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079040-001 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079040-002 | MORPHINE SULFATE | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079040-003 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079040-004 | MORPHINE SULFATE | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079040-005 | MORPHINE SULFATE | 90MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079040-006 | MORPHINE SULFATE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2013-01-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079040-001 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079040-002 | MORPHINE SULFATE | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079040-003 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079040-004 | MORPHINE SULFATE | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079040-005 | MORPHINE SULFATE | 90MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079040-006 | MORPHINE SULFATE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2013-01-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079040-001 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079040-002 | MORPHINE SULFATE | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079040-003 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079040-004 | MORPHINE SULFATE | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079040-005 | MORPHINE SULFATE | 90MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079040-006 | MORPHINE SULFATE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2013-01-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079040-001 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079040-002 | MORPHINE SULFATE | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079040-003 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079040-004 | MORPHINE SULFATE | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079040-005 | MORPHINE SULFATE | 90MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079040-006 | MORPHINE SULFATE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2013-01-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079040-001 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079040-002 | MORPHINE SULFATE | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079040-003 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079040-004 | MORPHINE SULFATE | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 03ed91905a0d… |
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 | Actavis Pharma, Inc. | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 2026-03-01 | Boxed warning, Warnings, Adverse reactions | 079040 ANDA079040 0228-3117 0228-3093 0228-3116 0228-3091 0228-3090 0228-3092 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0228-3090 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3090 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3090 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3090 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3090 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3090 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3091 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3091 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3091 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3091 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3091 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3091 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3092 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3092 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3092 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3092 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3092 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3092 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3093 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3093 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3093 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3093 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3093 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3093 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3116 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3116 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3116 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3116 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3116 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3116 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3117 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3117 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3117 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3117 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3117 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3117 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |