Application 074862

Type
ANDA
Sponsor
RHODES PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MORPHINE SULFATEMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL15MGNoNo
002MORPHINE SULFATEMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL30MGNoNo
003MORPHINE SULFATEMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL60MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074862-001MORPHINE SULFATEMORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07
A074862-002MORPHINE SULFATEMORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07
A074862-003MORPHINE SULFATEMORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A074862-001AB
A074862-002AB
A074862-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074862-002MORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALAB1998-07-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074862-003MORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-07-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074862-001MORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALAB1998-07-078072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074862-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074862-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074862-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074862-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074862-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074862-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074862-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074862-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074862-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074862-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074862-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074862-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074862-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074862-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074862-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074862-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074862-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074862-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074862-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074862-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074862-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074862-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074862-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074862-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074862-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074862-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074862-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074862-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074862-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074862-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074862-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074862-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074862-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074862-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074862-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074862-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074862-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074862-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074862-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074862-001AB18072bd15b7f6…

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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Morphine Sulfate Extended ReleaseMORPHINE SULFATEMajor Pharmaceuticalsdbb37dfd-0196-45f7-b9ca-393f56cf1d282026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074862
application number: ANDA074862
ndc (product): 0904-6559
ndc (product): 0904-6558
ndc (product): 0904-6557
Morphine Sulfate Extended ReleaseMORPHINE SULFATERhodes Pharmaceuticals LLC19c7d9cc-6ce2-4c5c-8c3f-c24fd33428042026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074862
application number: ANDA074862
ndc (product): 42858-803
ndc (product): 42858-801
ndc (product): 42858-802
Morphine Sulfate ERMORPHINE SULFATEBryant Ranch Prepack872ceecb-1f14-7a43-7451-e4650a01fbd92026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074862
application number: ANDA074862
ndc (product): 63629-4483
Morphine SulfateMORPHINE SULFATEBryant Ranch Prepackcc3b491c-a206-3027-54f0-f87c0dd40a7f2026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074862
application number: ANDA074862
ndc (product): 63629-4484
Morphine Sulfate Extended ReleaseMORPHINE SULFATEAmerican Health Packagingf915420d-981d-455b-b4cf-67c8e201a1362024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074862
application number: ANDA074862
ndc (product): 68084-157
ndc (product): 68084-158

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 52 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6557Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6557Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6557Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6557Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6558Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6558Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6558Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6558Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6559Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6559Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6559Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
0904-6559Morphine SulfateMorphine SulfateMajor PharmaceuticalsANDACurrent
35356-833morphine sulfatemorphine sulfateLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-833morphine sulfatemorphine sulfateLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-836morphine sulfatemorphine sulfateLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-836morphine sulfatemorphine sulfateLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-838Morphine SulfateMorphine SulfateLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-838Morphine SulfateMorphine SulfateLake Erie Medical DBA Quality Care Products LLCANDACurrent
42858-801Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
42858-801Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
42858-801Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
42858-802Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
42858-802Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
42858-802Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
42858-803Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
42858-803Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
42858-803Morphine SulfateMorphine SulfateRhodes Pharmaceuticals L. P.ANDACurrent
52959-185Morphine SulfateMorphine SulfateH.J. Harkins Company, Inc.ANDACurrent
52959-406Morphine SulfateMorphine SulfateH.J. Harkins Company, Inc.ANDACurrent
61919-923MORPHINE SULFATEMORPHINE SULFATEDIRECT RXANDACurrent
61919-966MORPHINE SULFATEMORPHINE SULFATEDirect_RxANDACurrent
61919-966MORPHINE SULFATEMORPHINE SULFATEDirect_RxANDACurrent
61919-966MORPHINE SULFATEMORPHINE SULFATEDirect_RxANDACurrent
61919-966MORPHINE SULFATEMORPHINE SULFATEDIRECT RXANDACurrent
63629-4483Morphine SulfateMorphine SulfateBryant Ranch PrepackANDACurrent
63629-4483Morphine SulfateMorphine SulfateBryant Ranch PrepackANDACurrent
63629-4484Morphine SulfateMorphine SulfateBryant Ranch PrepackANDACurrent
63629-4484Morphine SulfateMorphine SulfateBryant Ranch PrepackANDACurrent
63629-4484Morphine SulfateMorphine SulfateBryant Ranch PrepackANDACurrent
63629-4515morphine sulfatemorphine sulfateBryant Ranch PrepackANDACurrent
63629-4515Morphine SulfateMorphine SulfateBryant Ranch PrepackANDACurrent
67296-1561Morphine SulfateMorphine SulfateRedPharm Drug, Inc.ANDACurrent
67296-1561Morphine SulfateMorphine SulfateRedPharm Drug, Inc.ANDACurrent
67296-1561Morphine SulfateMorphine SulfateRedPharm Drug, Inc.ANDACurrent
68084-157Morphine SulfateMorphine SulfateAmerican Health PackagingANDACurrent
68084-157Morphine SulfateMorphine SulfateAmerican Health PackagingANDACurrent
68084-157Morphine SulfateMorphine SulfateAmerican Health PackagingANDACurrent
68084-157Morphine SulfateMorphine SulfateAmerican Health PackagingANDACurrent
68084-158Morphine SulfateMorphine SulfateAmerican Health PackagingANDACurrent
68084-158Morphine SulfateMorphine SulfateAmerican Health PackagingANDACurrent
68084-158Morphine SulfateMorphine SulfateAmerican Health PackagingANDACurrent
68084-158Morphine SulfateMorphine SulfateAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24049ORIG2015-06-30
42888ORIG1999-03-30
18369ORIG1998-07-07
8458ORIG1998-07-07