FDA.reportPublic FDA data

Application 201517

Type
NDA
Sponsor
LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MORPHINE SULFATEMORPHINE SULFATESOLUTION;ORAL100MG/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N201517-001MORPHINE SULFATEMORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-23

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-2384e616aacf4f…
2026-08-18 06:07:402026-07N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-2387673890dc5c…
2021-03-12 10:30 UTC2021-03N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-233f01610625f2…
2019-09-15 20:21 UTC2019-09N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-23b00525d2431f…
2019-07-19 19:46 UTC2019-07N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-233f0d92c62455…
2023-05-13 08:27 UTC2023-05N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-23053a50430f4f…
2023-01-26 05:58 UTC2023-01N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N201517-001MORPHINE SULFATE100MG/5MLSOLUTION / ORAL2011-06-23f41ea6bd6efb…

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.

Matched openFDA labels page 3 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INFUMORPH 200MORPHINE SULFATEHikma Pharmaceuticals USA Inc.db9ac9e3-d761-4a99-9f34-4946ebe8f2552025-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATERedpharm Drug300b6afd-bac8-32ca-e063-6294a90a12a72025-12-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Morphine Sulfate
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEUpsher-Smith Laboratories, LLC5ceb3205-2f8d-4ba3-9f27-dc328bab4fa12025-12-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Morphine Sulfate
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEAmerican Health Packagingd66d0cfb-9bfe-490c-90ee-49481c567e852025-12-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Morphine Sulfate
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEAmneal Pharmaceuticals of New York LLCf7e9a4b3-a2ee-4f0a-becd-6ef90867332b2025-11-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Morphine Sulfate
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEAmerican Health Packaging9f1ba2a2-d8ac-4f59-a587-fe413e56dcdb2025-11-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Morphine Sulfate
generic name: MORPHINE SULFATE
MORPHINE SULFATEMORPHINE SULFATEAscend Laboratories, LLC07593aa4-f2c4-4d6e-b186-ab2a4ecaa38a2025-10-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: MORPHINE SULFATE
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATENortec Development Associates, Inc.9c1a5b8b-8faa-4ee0-80bd-853c239bb1c42025-08-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Morphine Sulfate
generic name: MORPHINE SULFATE
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack47ea2424-ce2f-4b3b-b393-da1886e7a3832025-07-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Morphine sulfate
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATECivica, Inc.9362eca1-2bc9-4f72-8895-0b9179bfeb2b2025-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Morphine Sulfate
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEUpsher-Smith Laboratories, LLC97948a8f-7d1b-4614-b11d-e944cf56590b2025-07-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Morphine Sulfate
generic name: MORPHINE SULFATE
MORPHINE SULFATEMORPHINE SULFATEBryant Ranch Prepack905cd842-2c86-4318-a6c4-92f49de145b32025-06-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: MORPHINE SULFATE
generic name: MORPHINE SULFATE
Morphine Sulfate Extended ReleaseMORPHINE SULFATEAmerican Health Packagingf915420d-981d-455b-b4cf-67c8e201a1362024-12-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEInternational Medication Systems, Limited1034467f-d436-4b87-a902-c7e8885daa8a2024-12-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Morphine Sulfate
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEBryant Ranch Prepack9bb1fef7-4159-4dca-8a8c-37e53ccc6bab2024-12-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Morphine Sulfate
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEPAI Holdings, LLC dba PAI Pharma6e32b869-31c7-48c1-98ae-b21bd28151d72024-11-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Morphine Sulfate
generic name: MORPHINE SULFATE
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack2f15f27b-95ed-4cc8-8937-eae07917a6dd2024-08-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Morphine sulfate
generic name: MORPHINE SULFATE
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack20af0f0e-45cc-4795-97ef-90b659575b342024-08-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Morphine sulfate
generic name: MORPHINE SULFATE
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack3e310662-16e8-4179-883e-efbca736b14d2024-08-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Morphine sulfate
generic name: MORPHINE SULFATE
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack7f65fa22-c3fc-4413-8a07-2c6be621b7bf2024-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Morphine sulfate
generic name: MORPHINE SULFATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-1425Morphine SulfateMorphine SulfateLannett Company, Inc.NDACurrent
0527-1906Morphine SulfateMorphine SulfateLannett Company, Inc.NDACurrent
70166-101Morphine SulfateMorphine SulfateLohxaNDACurrent
71335-1696Morphine SulfateMorphine SulfateBryant Ranch PrepackNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84675SUPPL 2026-01-06
84571SUPPL 2025-12-29
77053SUPPL 2023-12-19
77016SUPPL 2023-12-19
76953SUPPL 2023-12-18
76243ORIG 2023-11-03
66637SUPPL2021-03-08
66636SUPPL2021-03-08
66574SUPPL2021-03-08
60406SUPPL2019-10-09
60401SUPPL2019-10-08
60400SUPPL2019-10-08
55714SUPPL2018-10-01
55713SUPPL2018-10-01
55574SUPPL2018-09-24
55573SUPPL2018-09-24
46422SUPPL2016-12-21
46308SUPPL2016-12-20
43367ORIG2012-01-12
24394ORIG2012-01-12
32113ORIG2011-06-29
19018ORIG2011-06-28