Application 020616

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KADIANMORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORAL20MGYesNo
002KADIANMORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORAL50MGYesNo
003KADIANMORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORAL100MGYesYes
004KADIANMORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORAL30MGYesNo
005KADIANMORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORAL60MGYesNo
006KADIANMORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORAL80MGYesNo
007KADIANMORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORAL200MGYesYes
008KADIANMORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORAL10MGYesYes
009KADIANMORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORAL40MGYesNo
010KADIANMORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORAL70MGYesNo
011KADIANMORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORAL130MGYesNo
012KADIANMORPHINE SULFATECAPSULE, EXTENDED RELEASE;ORAL150MGYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020616-001KADIANMORPHINE SULFATE20MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-03
N020616-002KADIANMORPHINE SULFATE50MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-03
N020616-003KADIANMORPHINE SULFATE100MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-03
N020616-004KADIANMORPHINE SULFATE30MGCAPSULE, EXTENDED RELEASE / ORALRLD2001-03-09
N020616-005KADIANMORPHINE SULFATE60MGCAPSULE, EXTENDED RELEASE / ORALRLD2001-03-09
N020616-006KADIANMORPHINE SULFATE80MGCAPSULE, EXTENDED RELEASE / ORALRLD2006-10-27
N020616-007KADIANMORPHINE SULFATE200MGCAPSULE, EXTENDED RELEASE / ORALRLD2007-02-27
N020616-008KADIANMORPHINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORALRLD2007-04-20
N020616-009KADIANMORPHINE SULFATE40MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09
N020616-010KADIANMORPHINE SULFATE70MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09
N020616-011KADIANMORPHINE SULFATE130MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09
N020616-012KADIANMORPHINE SULFATE150MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09

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 13 · 504 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020616-001KADIAN20MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07N020616-002KADIAN50MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07N020616-003KADIAN100MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07N020616-004KADIAN30MGCAPSULE, EXTENDED RELEASE / ORALRLD2001-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07N020616-005KADIAN60MGCAPSULE, EXTENDED RELEASE / ORALRLD2001-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07N020616-006KADIAN80MGCAPSULE, EXTENDED RELEASE / ORALRLD2006-10-27caaa826d4ba7…
2026-08-18 06:07:402026-07N020616-007KADIAN200MGCAPSULE, EXTENDED RELEASE / ORALRLD2007-02-27caaa826d4ba7…
2026-08-18 06:07:402026-07N020616-008KADIAN10MGCAPSULE, EXTENDED RELEASE / ORALRLD2007-04-20caaa826d4ba7…
2026-08-18 06:07:402026-07N020616-009KADIAN40MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07N020616-010KADIAN70MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07N020616-011KADIAN130MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07N020616-012KADIAN150MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020616-001KADIAN20MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020616-002KADIAN50MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020616-003KADIAN100MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020616-004KADIAN30MGCAPSULE, EXTENDED RELEASE / ORALRLD2001-03-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020616-005KADIAN60MGCAPSULE, EXTENDED RELEASE / ORALRLD2001-03-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020616-006KADIAN80MGCAPSULE, EXTENDED RELEASE / ORALRLD2006-10-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020616-007KADIAN200MGCAPSULE, EXTENDED RELEASE / ORALRLD2007-02-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020616-008KADIAN10MGCAPSULE, EXTENDED RELEASE / ORALRLD2007-04-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020616-009KADIAN40MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020616-010KADIAN70MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020616-011KADIAN130MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020616-012KADIAN150MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-001KADIAN20MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-002KADIAN50MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-003KADIAN100MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-004KADIAN30MGCAPSULE, EXTENDED RELEASE / ORALRLD2001-03-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-005KADIAN60MGCAPSULE, EXTENDED RELEASE / ORALRLD2001-03-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-006KADIAN80MGCAPSULE, EXTENDED RELEASE / ORALRLD2006-10-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-007KADIAN200MGCAPSULE, EXTENDED RELEASE / ORALRLD2007-02-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-008KADIAN10MGCAPSULE, EXTENDED RELEASE / ORALRLD2007-04-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-009KADIAN40MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-010KADIAN70MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-011KADIAN130MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-012KADIAN150MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N020616-001KADIAN20MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020616-002KADIAN50MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020616-003KADIAN100MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020616-004KADIAN30MGCAPSULE, EXTENDED RELEASE / ORALRLD2001-03-096a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N020616-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020616-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020616-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020616-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020616-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020616-006AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020616-008AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020616-009AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020616-010AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020616-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020616-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020616-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020616-004AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020616-005AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020616-006AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020616-008AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020616-009AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020616-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020616-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020616-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020616-004AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020616-005AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020616-006AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020616-008AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020616-009AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020616-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020616-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020616-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020616-004AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020616-005AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020616-006AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020616-008AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020616-009AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020616-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020616-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020616-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020616-004AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020616-005AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020616-006AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020616-008AB1c0c555d07b60…

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 1 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Morphine SulfateMORPHINE SULFATERedpharm Drug58476a6b-b54b-5491-e063-6394a90a38c62026-08-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATESpecGx LLC8b69f67f-30b3-4982-953e-5a4b87ec6ac62026-07-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
MORPHINE SULFATEMORPHINE SULFATESt. Mary's Medical Park Pharmacy57ee014e-744e-65e1-e063-6394a90a8c932026-07-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATESpecGx LLC242c2512-1d49-486b-a9c3-6905f667799e2026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack595243fe-a4b1-479a-99d6-a084a41818912026-07-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEHikma Pharmaceuticals USA Inc.6023606c-150c-40c5-9175-598efe2a56c32026-07-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEHikma Pharmaceuticals USA Inc.69a0d5be-3211-4b7f-962b-e9d9a507321f2026-07-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEPrecision Dose, Inc.6654b91e-3b3f-4062-ac65-a2a70f942da42026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEPrecision Dose, Inc.bb6b3439-9f0c-45f5-bf6f-c7a971af0a8f2026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEPrecision Dose, Inc.76966c05-df75-4072-ae99-97e42f91ab752026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEPrecision Dose, Inc.67f0ee8d-696e-4c08-9007-3df0e3988bad2026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine Sulfate Extended ReleaseMORPHINE SULFATEMajor Pharmaceuticalsdbb37dfd-0196-45f7-b9ca-393f56cf1d282026-05-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEBryant Ranch Prepack367d508b-3226-42a9-8dc6-f67cdc9979f32026-05-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEPrecision Dose Inc.8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc2026-05-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
MS ContinMORPHINE SULFATERhodes Pharmaceuticals LLCc354b3bf-86c0-4bb8-8b1f-be21649426982026-05-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine Sulfate Extended ReleaseMORPHINE SULFATERhodes Pharmaceuticals LLC19c7d9cc-6ce2-4c5c-8c3f-c24fd33428042026-05-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEAmerican Health Packaging5422cdac-8073-41fc-8665-ffe9797f5c022026-05-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEHospira, Inc.1d181906-f3ec-4222-1883-e61577a3122e2026-04-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine Sulfate Extended ReleaseMORPHINE SULFATEBryant Ranch Prepack2dd52157-3121-41ed-abc2-99b269531e562026-04-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
MORPHINE SULFATEMORPHINE SULFATEBryant Ranch Prepackd1b0b4ac-69d9-44bf-b7a3-229bd89b9fd62026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 118 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-6011Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6011Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6011Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6011Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6011Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6011Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6012Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6012Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6012Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6012Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6012Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6012Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6013Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6013Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6013Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6013Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6013Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6013Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6014Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6014Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6014Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6014Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6014Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6015Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6015Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6015Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6015Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6015Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6015Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6016Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6016Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6016Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6016Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6016Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6016Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6017Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6017Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6017Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6017Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6017Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6017Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6018Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6018Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6018Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6018Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6018Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6018Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6019Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6019Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6019Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6019Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6019Kadianmorphine sulfateAllergan, Inc.NDACurrent
0023-6019Kadianmorphine sulfateAllergan, Inc.NDACurrent
0228-3501Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3501Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3501Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3501Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3501Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3501Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3501Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3502Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3502Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3502Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3502Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3502Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3502Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3502Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3503Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3503Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3503Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3503Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3503Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3503Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3503Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3504Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3504Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3504Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3504Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3504Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0228-3504Morphine sulfateMorphine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66587SUPPL2021-03-08
66586SUPPL2021-03-08
66505SUPPL2021-03-05
60343SUPPL2019-10-08
60329SUPPL2019-10-08
60328SUPPL2019-10-08
55901SUPPL2018-10-12
55900SUPPL2018-10-12
55661SUPPL2018-09-28
55660SUPPL2018-09-28
48568SUPPL2017-05-30
46383SUPPL2016-12-21
46253SUPPL2016-12-20
45462SUPPL2016-10-04
2888SUPPL2016-04-22
2887SUPPL2015-07-02
2886SUPPL2014-08-20
2885SUPPL2014-04-17
34964SUPPL2014-04-16
25330SUPPL2013-04-17
2884SUPPL2013-03-29
34963SUPPL2012-07-13
34962SUPPL2012-07-12
44453ORIG2012-07-11
25329SUPPL2012-07-11
20768SUPPL2011-02-04
41484SUPPL2007-11-19
41483SUPPL2007-11-19
25328SUPPL2007-05-01
12854SUPPL2007-04-25
34960SUPPL2007-03-07
25327SUPPL2007-03-07
12853SUPPL2007-03-07
2882SUPPL2007-03-07
34961SUPPL2006-11-06
2883SUPPL2006-11-06
25326SUPPL2005-10-20
12852SUPPL2005-09-30