Application 203045

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISENTRESSRALTEGRAVIR POTASSIUMTABLET, CHEWABLE;ORALEQ 25MG BASEYesNo
002ISENTRESSRALTEGRAVIR POTASSIUMTABLET, CHEWABLE;ORALEQ 100MG BASEYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N203045-001ISENTRESSRALTEGRAVIR POTASSIUMEQ 25MG BASETABLET, CHEWABLE / ORALRLD2011-12-21
N203045-002ISENTRESSRALTEGRAVIR POTASSIUMEQ 100MG BASETABLET, CHEWABLE / ORALRLD, RS2011-12-21

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N203045-00177547312029-03-11U-257Drug substance, Drug product2012-01-20
N203045-0017754731*PED2029-09-11Pediatric extension
N203045-00277547312029-03-11U-257Drug substance, Drug product
N203045-0027754731*PED2029-09-11Pediatric extension
N203045-00287717332030-06-02U-257Drug substance, Drug product2023-03-27

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 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N203045-001ISENTRESSEQ 25MG BASETABLET, CHEWABLE / ORALRLD2011-12-21c2088c7a36db…
2026-10-15 13:18:302026-09N203045-002ISENTRESSEQ 100MG BASETABLET, CHEWABLE / ORALRLD, RS2011-12-21c2088c7a36db…
2026-09-14 22:38:342026-08N203045-001ISENTRESSEQ 25MG BASETABLET, CHEWABLE / ORALRLD2011-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N203045-002ISENTRESSEQ 100MG BASETABLET, CHEWABLE / ORALRLD, RS2011-12-2184e616aacf4f…
2026-08-18 06:07:402026-07N203045-001ISENTRESSEQ 25MG BASETABLET, CHEWABLE / ORALRLD2011-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N203045-002ISENTRESSEQ 100MG BASETABLET, CHEWABLE / ORALRLD, RS2011-12-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N203045-001ISENTRESSEQ 25MG BASETABLET, CHEWABLE / ORALRLD2011-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203045-002ISENTRESSEQ 100MG BASETABLET, CHEWABLE / ORALRLD, RS2011-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203045-001ISENTRESSEQ 25MG BASETABLET, CHEWABLE / ORALRLD2011-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203045-002ISENTRESSEQ 100MG BASETABLET, CHEWABLE / ORALRLD, RS2011-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N203045-001ISENTRESSEQ 25MG BASETABLET, CHEWABLE / ORALRLD2011-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203045-002ISENTRESSEQ 100MG BASETABLET, CHEWABLE / ORALRLD, RS2011-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203045-001ISENTRESSEQ 25MG BASETABLET, CHEWABLE / ORALRLD2011-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203045-002ISENTRESSEQ 100MG BASETABLET, CHEWABLE / ORALRLD, RS2011-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203045-001ISENTRESSEQ 25MG BASETABLET, CHEWABLE / ORALRLD2011-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203045-002ISENTRESSEQ 100MG BASETABLET, CHEWABLE / ORALRLD, RS2011-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203045-001ISENTRESSEQ 25MG BASETABLET, CHEWABLE / ORALRLD2011-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203045-002ISENTRESSEQ 100MG BASETABLET, CHEWABLE / ORALRLD, RS2011-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203045-001ISENTRESSEQ 25MG BASETABLET, CHEWABLE / ORALRLD2011-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203045-002ISENTRESSEQ 100MG BASETABLET, CHEWABLE / ORALRLD, RS2011-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203045-001ISENTRESSEQ 25MG BASETABLET, CHEWABLE / ORALRLD2011-12-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203045-002ISENTRESSEQ 100MG BASETABLET, CHEWABLE / ORALRLD, RS2011-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203045-001ISENTRESSEQ 25MG BASETABLET, CHEWABLE / ORALRLD2011-12-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203045-002ISENTRESSEQ 100MG BASETABLET, CHEWABLE / ORALRLD, RS2011-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N203045-001ISENTRESSEQ 25MG BASETABLET, CHEWABLE / ORALRLD2011-12-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N203045-002ISENTRESSEQ 100MG BASETABLET, CHEWABLE / ORALRLD, RS2011-12-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203045-001ISENTRESSEQ 25MG BASETABLET, CHEWABLE / ORALRLD2011-12-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203045-002ISENTRESSEQ 100MG BASETABLET, CHEWABLE / ORALRLD, RS2011-12-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203045-001ISENTRESSEQ 25MG BASETABLET, CHEWABLE / ORALRLD2011-12-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203045-002ISENTRESSEQ 100MG BASETABLET, CHEWABLE / ORALRLD, RS2011-12-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N203045-001ISENTRESSEQ 25MG BASETABLET, CHEWABLE / ORALRLD2011-12-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N203045-002ISENTRESSEQ 100MG BASETABLET, CHEWABLE / ORALRLD, RS2011-12-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N203045-001ISENTRESSEQ 25MG BASETABLET, CHEWABLE / ORALRLD2011-12-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05N203045-002ISENTRESSEQ 100MG BASETABLET, CHEWABLE / ORALRLD, RS2011-12-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N203045-001ISENTRESSEQ 25MG BASETABLET, CHEWABLE / ORALRLD2011-12-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N203045-002ISENTRESSEQ 100MG BASETABLET, CHEWABLE / ORALRLD, RS2011-12-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N203045-001ISENTRESSEQ 25MG BASETABLET, CHEWABLE / ORALRLD2011-12-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N203045-002ISENTRESSEQ 100MG BASETABLET, CHEWABLE / ORALRLD, RS2011-12-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N203045-001ISENTRESSEQ 25MG BASETABLET, CHEWABLE / ORALRLD2011-12-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N203045-002ISENTRESSEQ 100MG BASETABLET, CHEWABLE / ORALRLD, RS2011-12-214b0b4de00fa7…

Observed Orange Book patent history#

Patent history page 5 of 13 · 488 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N203045-00274357342022-10-21U-25774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N203045-0027217713*PED2023-04-21Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N203045-0027435734*PED2023-04-21Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N203045-00271697802023-10-03Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N203045-0027169780*PED2024-04-03Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N203045-00277547312029-03-11U-257Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N203045-0027754731*PED2029-09-11Pediatric extension74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N203045-00172177132022-10-21U-2572012-01-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N203045-00174357342022-10-21U-2572012-01-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N203045-0017217713*PED2023-04-21Pediatric extensionbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N203045-0017435734*PED2023-04-21Pediatric extensionbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N203045-00171697802023-10-03Drug substance, Drug product2012-01-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N203045-0017169780*PED2024-04-03Pediatric extensionbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N203045-00177547312029-03-11U-257Drug substance, Drug product2012-01-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N203045-0017754731*PED2029-09-11Pediatric extensionbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N203045-00272177132022-10-21U-257bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N203045-00274357342022-10-21U-257bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N203045-0027217713*PED2023-04-21Pediatric extensionbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N203045-0027435734*PED2023-04-21Pediatric extensionbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N203045-00271697802023-10-03Drug substance, Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N203045-0027169780*PED2024-04-03Pediatric extensionbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N203045-00277547312029-03-11U-257Drug substance, Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N203045-0027754731*PED2029-09-11Pediatric extensionbb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N203045-00172177132022-10-21U-2572012-01-20782e0a99824c…
2021-12-28 21:50 UTC2021-12N203045-00174357342022-10-21U-2572012-01-20782e0a99824c…
2021-12-28 21:50 UTC2021-12N203045-0017217713*PED2023-04-21Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N203045-0017435734*PED2023-04-21Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N203045-00171697802023-10-03Drug substance, Drug product2012-01-20782e0a99824c…
2021-12-28 21:50 UTC2021-12N203045-0017169780*PED2024-04-03Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N203045-00177547312029-03-11U-257Drug substance, Drug product2012-01-20782e0a99824c…
2021-12-28 21:50 UTC2021-12N203045-0017754731*PED2029-09-11Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N203045-00272177132022-10-21U-257782e0a99824c…
2021-12-28 21:50 UTC2021-12N203045-00274357342022-10-21U-257782e0a99824c…
2021-12-28 21:50 UTC2021-12N203045-0027217713*PED2023-04-21Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N203045-0027435734*PED2023-04-21Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N203045-00271697802023-10-03Drug substance, Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N203045-0027169780*PED2024-04-03Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N203045-00277547312029-03-11U-257Drug substance, Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N203045-0027754731*PED2029-09-11Pediatric extension782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N203045-00172177132022-10-21U-2572012-01-2087673890dc5c…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N203045-001NPP2020-11-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N203045-001PED2021-05-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N203045-002NPP2020-11-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N203045-002PED2021-05-2274a2ff9319b5…
2021-12-28 21:50 UTC2021-12N203045-001PED2021-05-22782e0a99824c…
2021-12-28 21:50 UTC2021-12N203045-002PED2021-05-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N203045-001PED2021-05-2287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N203045-002PED2021-05-2287673890dc5c…
2021-03-12 10:30 UTC2021-03N203045-001PED2021-05-225aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N203045-002PED2021-05-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N203045-001NPP2020-11-228869cabd3fbd…
2020-12-22 03:56 UTC2020-12N203045-001PED2021-05-228869cabd3fbd…
2020-12-22 03:56 UTC2020-12N203045-002NPP2020-11-228869cabd3fbd…
2020-12-22 03:56 UTC2020-12N203045-002PED2021-05-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11N203045-001NPP2020-11-22c0c555d07b60…
2020-11-12 02:37 UTC2020-11N203045-001PED2021-05-22c0c555d07b60…
2020-11-12 02:37 UTC2020-11N203045-002NPP2020-11-22c0c555d07b60…
2020-11-12 02:37 UTC2020-11N203045-002PED2021-05-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12N203045-001NPP2020-11-223f01610625f2…
2019-12-14 00:12 UTC2019-12N203045-001PED2021-05-223f01610625f2…
2019-12-14 00:12 UTC2019-12N203045-002NPP2020-11-223f01610625f2…
2019-12-14 00:12 UTC2019-12N203045-002PED2021-05-223f01610625f2…
2019-09-15 20:21 UTC2019-09N203045-001NPP2020-11-22b00525d2431f…
2019-09-15 20:21 UTC2019-09N203045-001PED2021-05-22b00525d2431f…
2019-09-15 20:21 UTC2019-09N203045-002NPP2020-11-22b00525d2431f…
2019-09-15 20:21 UTC2019-09N203045-002PED2021-05-22b00525d2431f…
2019-07-19 19:46 UTC2019-07N203045-001NPP2020-11-22ea99ee380514…
2019-07-19 19:46 UTC2019-07N203045-001PED2021-05-22ea99ee380514…
2019-07-19 19:46 UTC2019-07N203045-002NPP2020-11-22ea99ee380514…
2019-07-19 19:46 UTC2019-07N203045-002PED2021-05-22ea99ee380514…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ISENTRESSRALTEGRAVIRMerck Sharp & Dohme LLC89a5ec53-d956-4329-8004-0f40f51c88a32024-10-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 203045
application number: NDA203045
ndc (product): 0006-0473
ndc (product): 0006-0477

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-0473ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-0473ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-0473ISENTRESSRALTEGRAVIRMerck Sharp & Dohme LLCNDACurrent
0006-0473ISENTRESSRALTEGRAVIRMerck Sharp & Dohme LLCNDACurrent
0006-0473ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-0473ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-0477ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-0477ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-0477ISENTRESSRALTEGRAVIRMerck Sharp & Dohme LLCNDACurrent
0006-0477ISENTRESSRALTEGRAVIRMerck Sharp & Dohme LLCNDACurrent
0006-0477ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-0477ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67558SUPPL2021-05-20
67554SUPPL2021-05-19
63956SUPPL2020-07-17
63941SUPPL2020-07-16
52912SUPPL2018-03-12
52828SUPPL2018-03-06
50504SUPPL2017-12-06
50475SUPPL2017-11-24
48598SUPPL2017-05-31
48578SUPPL2017-05-31
32360SUPPL2015-02-24
40253SUPPL2015-02-23
40252SUPPL2015-02-20
10150SUPPL2015-02-19
40251SUPPL2014-04-10
32359SUPPL2014-04-10
32358SUPPL2013-12-31
40250SUPPL2013-12-23
32357SUPPL2013-10-25
19413SUPPL2013-10-25
32356SUPPL2013-08-06
19412SUPPL2013-08-06
40249SUPPL2013-07-03
10148SUPPL2013-07-02
19411SUPPL2013-04-09
10149SUPPL2013-04-09
40248SUPPL2012-08-15
32355SUPPL2012-08-15
44874ORIG2012-04-30
22906ORIG2012-04-30
32354SUPPL2012-04-23
19410SUPPL2012-04-20
32353SUPPL2012-04-02
19409SUPPL2012-03-28
32352ORIG2011-12-27
19408ORIG2011-12-23