Application 078761
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MORPHINE SULFATE | MORPHINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 15MG | No | No |
| 002 | MORPHINE SULFATE | MORPHINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 30MG | No | No |
| 003 | MORPHINE SULFATE | MORPHINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 60MG | No | No |
| 004 | MORPHINE SULFATE | MORPHINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 005 | MORPHINE SULFATE | MORPHINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 200MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078761-001 | MORPHINE SULFATE | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | |
| A078761-002 | MORPHINE SULFATE | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | |
| A078761-003 | MORPHINE SULFATE | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | |
| A078761-004 | MORPHINE SULFATE | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | |
| A078761-005 | MORPHINE SULFATE | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078761-001 | AB |
| A078761-002 | AB |
| A078761-003 | AB |
| A078761-004 | AB |
| A078761-005 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078761-001 | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078761-002 | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078761-003 | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078761-004 | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078761-005 | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078761-001 | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078761-002 | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078761-003 | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078761-004 | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078761-005 | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078761-001 | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078761-002 | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078761-003 | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078761-004 | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078761-005 | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078761-001 | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078761-002 | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078761-003 | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078761-004 | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078761-005 | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078761-001 | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078761-002 | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078761-003 | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078761-004 | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078761-005 | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078761-001 | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078761-002 | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078761-003 | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078761-004 | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078761-005 | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078761-001 | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078761-002 | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078761-003 | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078761-004 | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078761-005 | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078761-001 | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078761-002 | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078761-003 | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078761-004 | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078761-005 | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-05-11 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078761-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078761-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078761-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078761-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078761-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078761-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078761-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078761-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078761-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078761-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078761-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078761-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078761-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078761-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078761-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078761-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078761-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078761-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078761-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078761-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078761-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078761-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078761-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078761-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078761-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078761-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078761-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078761-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078761-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078761-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078761-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078761-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078761-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078761-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078761-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078761-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078761-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078761-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078761-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078761-005 | AB | 1 | 5bbf6a4d5a75… |
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 | Bryant Ranch Prepack | 595243fe-a4b1-479a-99d6-a084a4181891 | 2026-07-13 | Boxed warning, Warnings, Adverse reactions | 078761 ANDA078761 63629-1091 |
| Morphine sulfate | MORPHINE SULFATE | Sun Pharmaceutical Industries, Inc. | 736c9b80-682c-4cda-bf18-61b18de0bd39 | 2026-03-15 | Boxed warning, Warnings, Adverse reactions | 078761 ANDA078761 63304-453 63304-758 63304-450 63304-451 63304-452 |
| Morphine sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | 07993f6c-146b-4728-a2da-6e93089f78ff | 2026-02-13 | Boxed warning, Warnings, Adverse reactions | 078761 ANDA078761 |
| Morphine sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | 3a89d0ca-4ff8-4bdc-8ea8-9ad591ce7226 | 2026-01-22 | Boxed warning, Warnings, Adverse reactions | 078761 ANDA078761 |
| Morphine sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | 47ea2424-ce2f-4b3b-b393-da1886e7a383 | 2025-07-30 | Boxed warning, Warnings, Adverse reactions | 078761 ANDA078761 71335-0707 |
| Morphine sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | 2f15f27b-95ed-4cc8-8937-eae07917a6dd | 2024-08-22 | Boxed warning, Warnings, Adverse reactions | 078761 ANDA078761 63629-1087 |
| Morphine sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | 20af0f0e-45cc-4795-97ef-90b659575b34 | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | 078761 ANDA078761 |
| Morphine sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | 3e310662-16e8-4179-883e-efbca736b14d | 2024-08-05 | Boxed warning, Warnings, Adverse reactions | 078761 ANDA078761 63629-1089 |
| Morphine sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | 7f65fa22-c3fc-4413-8a07-2c6be621b7bf | 2024-07-10 | Boxed warning, Warnings, Adverse reactions | 078761 ANDA078761 |
| Morphine sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | fd98b881-5466-457b-b5af-f102aec61546 | 2024-06-05 | Boxed warning, Warnings, Adverse reactions | 078761 ANDA078761 63629-1088 |
| Morphine sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | 9a1ca529-8268-4be3-b03f-b2f2238cc9dc | 2024-04-04 | Boxed warning, Warnings, Adverse reactions | 078761 ANDA078761 |
| Morphine sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | fb9f929b-8c5a-442b-9695-9d3d45272a5e | 2024-04-04 | Boxed warning, Warnings, Adverse reactions | 078761 ANDA078761 |
| Morphine sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | 73a39ce5-b2ab-47b9-8860-796f1d5bc8d8 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 078761 ANDA078761 71335-0736 |
| Morphine sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | ad08cd86-3825-4e77-bbe8-f6333a9ca9d7 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 078761 ANDA078761 71335-0676 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55700-824 | Morphine sulfate | morphine sulfate | Quality Care Products, LLC | ANDA | Current |
| 55700-824 | Morphine sulfate | morphine sulfate | Quality Care Products, LLC | ANDA | Current |
| 55700-824 | Morphine sulfate | morphine sulfate | Quality Care Products, LLC | ANDA | Current |
| 55700-825 | Morphine sulfate | morphine sulfate | Quality Care Products, LLC | ANDA | Current |
| 55700-825 | Morphine sulfate | morphine sulfate | Quality Care Products, LLC | ANDA | Current |
| 55700-825 | Morphine sulfate | morphine sulfate | Quality Care Products, LLC | ANDA | Current |
| 55700-825 | Morphine sulfate | morphine sulfate | Quality Care Products, LLC | ANDA | Current |
| 55700-825 | Morphine sulfate | morphine sulfate | Quality Care Products, LLC | ANDA | Current |
| 63304-450 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-450 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-450 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-451 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-451 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-451 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-452 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-452 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-452 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-453 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-453 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-453 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-758 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-758 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-758 | Morphine sulfate | morphine sulfate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63629-1087 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1087 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1087 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1088 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1088 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1088 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1089 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1089 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1089 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1090 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1090 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1090 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1091 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1091 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1091 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1091 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0676 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0676 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0676 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0707 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0707 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0707 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0736 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0736 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0736 | Morphine sulfate | morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 24063 | ORIG | 2015-03-24 |