FDA.reportPublic FDA data

Application 208259

Type
NDA
Sponsor
AERIE PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROCKLATANLATANOPROST; NETARSUDIL DIMESYLATESOLUTION/DROPS;OPHTHALMIC0.005%;EQ 0.02% BASEYesYes

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

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
N208259-001ROCKLATANLATANOPROST; NETARSUDIL DIMESYLATE0.005%;EQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2019-03-12

Orange Book patents#

Current patent rows page 1 of 1 · 17 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208259-001105329932026-07-11U-15242020-03-30
N208259-001108828402026-07-11U-15242021-01-22
N208259-001110214562026-07-11U-15242021-06-28
N208259-00184503442026-07-11U-1524Drug substance, Drug product2019-03-28
N208259-00190965692026-07-11U-1524Drug substance, Drug product2019-03-28
N208259-001101740172030-01-27U-1524Drug substance, Drug product2019-03-28
N208259-001106548442030-01-27U-1524Drug substance, Drug product2020-06-10
N208259-001110280812030-01-27U-15242021-06-28
N208259-001116187482030-01-27U-15242023-04-21
N208259-00183948262030-11-10U-1524Drug substance, Drug product2019-03-28
N208259-001105889012034-03-14U-1524Drug substance, Drug product2020-04-15
N208259-001110203852034-03-14U-15242024-07-12
N208259-001111855382034-03-14Drug product2021-12-16
N208259-001111978532034-03-14Drug product2021-12-16
N208259-00194150432034-03-14Drug substance2019-03-28
N208259-00199313362034-03-14U-1524Drug substance, Drug product2019-03-28
N208259-00199934702034-03-14U-1524Drug substance, Drug product2019-03-28

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N208259-001ROCKLATAN0.005%;EQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2019-03-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208259-001ROCKLATAN0.005%;EQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2019-03-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208259-001ROCKLATAN0.005%;EQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2019-03-12cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N208259-001ROCKLATAN0.005%;EQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2019-03-12a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 17 · 648 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N208259-001105329932026-07-11U-15242020-03-30c2088c7a36db…
2026-10-15 13:18:302026-09N208259-001108828402026-07-11U-15242021-01-22c2088c7a36db…
2026-10-15 13:18:302026-09N208259-001110214562026-07-11U-15242021-06-28c2088c7a36db…
2026-10-15 13:18:302026-09N208259-00184503442026-07-11U-1524Drug substance, Drug product2019-03-28c2088c7a36db…
2026-10-15 13:18:302026-09N208259-00190965692026-07-11U-1524Drug substance, Drug product2019-03-28c2088c7a36db…
2026-10-15 13:18:302026-09N208259-001101740172030-01-27U-1524Drug substance, Drug product2019-03-28c2088c7a36db…
2026-10-15 13:18:302026-09N208259-001106548442030-01-27U-1524Drug substance, Drug product2020-06-10c2088c7a36db…
2026-10-15 13:18:302026-09N208259-001110280812030-01-27U-15242021-06-28c2088c7a36db…
2026-10-15 13:18:302026-09N208259-001116187482030-01-27U-15242023-04-21c2088c7a36db…
2026-10-15 13:18:302026-09N208259-00183948262030-11-10U-1524Drug substance, Drug product2019-03-28c2088c7a36db…
2026-10-15 13:18:302026-09N208259-001105889012034-03-14U-1524Drug substance, Drug product2020-04-15c2088c7a36db…
2026-10-15 13:18:302026-09N208259-001110203852034-03-14U-15242024-07-12c2088c7a36db…
2026-10-15 13:18:302026-09N208259-001111855382034-03-14Drug product2021-12-16c2088c7a36db…
2026-10-15 13:18:302026-09N208259-001111978532034-03-14Drug product2021-12-16c2088c7a36db…
2026-10-15 13:18:302026-09N208259-00194150432034-03-14Drug substance2019-03-28c2088c7a36db…
2026-10-15 13:18:302026-09N208259-00199313362034-03-14U-1524Drug substance, Drug product2019-03-28c2088c7a36db…
2026-10-15 13:18:302026-09N208259-00199934702034-03-14U-1524Drug substance, Drug product2019-03-28c2088c7a36db…
2026-09-14 22:38:342026-08N208259-001105329932026-07-11U-15242020-03-3084e616aacf4f…
2026-09-14 22:38:342026-08N208259-001108828402026-07-11U-15242021-01-2284e616aacf4f…
2026-09-14 22:38:342026-08N208259-001110214562026-07-11U-15242021-06-2884e616aacf4f…
2026-09-14 22:38:342026-08N208259-00184503442026-07-11U-1524Drug substance, Drug product2019-03-2884e616aacf4f…
2026-09-14 22:38:342026-08N208259-00190965692026-07-11U-1524Drug substance, Drug product2019-03-2884e616aacf4f…
2026-09-14 22:38:342026-08N208259-001101740172030-01-27U-1524Drug substance, Drug product2019-03-2884e616aacf4f…
2026-09-14 22:38:342026-08N208259-001106548442030-01-27U-1524Drug substance, Drug product2020-06-1084e616aacf4f…
2026-09-14 22:38:342026-08N208259-001110280812030-01-27U-15242021-06-2884e616aacf4f…
2026-09-14 22:38:342026-08N208259-001116187482030-01-27U-15242023-04-2184e616aacf4f…
2026-09-14 22:38:342026-08N208259-00183948262030-11-10U-1524Drug substance, Drug product2019-03-2884e616aacf4f…
2026-09-14 22:38:342026-08N208259-001105889012034-03-14U-1524Drug substance, Drug product2020-04-1584e616aacf4f…
2026-09-14 22:38:342026-08N208259-001110203852034-03-14U-15242024-07-1284e616aacf4f…
2026-09-14 22:38:342026-08N208259-001111855382034-03-14Drug product2021-12-1684e616aacf4f…
2026-09-14 22:38:342026-08N208259-001111978532034-03-14Drug product2021-12-1684e616aacf4f…
2026-09-14 22:38:342026-08N208259-00194150432034-03-14Drug substance2019-03-2884e616aacf4f…
2026-09-14 22:38:342026-08N208259-00199313362034-03-14U-1524Drug substance, Drug product2019-03-2884e616aacf4f…
2026-09-14 22:38:342026-08N208259-00199934702034-03-14U-1524Drug substance, Drug product2019-03-2884e616aacf4f…
2026-08-18 06:07:402026-07N208259-001105329932026-07-11U-15242020-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07N208259-001108828402026-07-11U-15242021-01-22caaa826d4ba7…
2026-08-18 06:07:402026-07N208259-001110214562026-07-11U-15242021-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07N208259-00184503442026-07-11U-1524Drug substance, Drug product2019-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07N208259-00190965692026-07-11U-1524Drug substance, Drug product2019-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07N208259-001101740172030-01-27U-1524Drug substance, Drug product2019-03-28caaa826d4ba7…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208259-001NC2022-03-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208259-001NCE2022-12-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208259-001NC2022-03-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N208259-001NCE2022-12-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208259-001NC2022-03-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N208259-001NCE2022-12-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208259-001NC2022-03-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N208259-001NCE2022-12-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208259-001NC2022-03-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N208259-001NCE2022-12-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208259-001NC2022-03-12782e0a99824c…
2021-12-28 21:50 UTC2021-12N208259-001NCE2022-12-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208259-001NC2022-03-1287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208259-001NCE2022-12-1887673890dc5c…
2021-03-12 10:30 UTC2021-03N208259-001NC2022-03-125aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N208259-001NCE2022-12-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208259-001NC2022-03-128869cabd3fbd…
2020-12-22 03:56 UTC2020-12N208259-001NCE2022-12-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208259-001NC2022-03-12c0c555d07b60…
2020-11-12 02:37 UTC2020-11N208259-001NCE2022-12-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208259-001NC2022-03-123f01610625f2…
2019-12-14 00:12 UTC2019-12N208259-001NCE2022-12-183f01610625f2…
2019-09-15 20:21 UTC2019-09N208259-001NC2022-03-12b00525d2431f…
2019-09-15 20:21 UTC2019-09N208259-001NCE2022-12-18b00525d2431f…
2019-07-19 19:46 UTC2019-07N208259-001NC2022-03-12ea99ee380514…
2019-07-19 19:46 UTC2019-07N208259-001NCE2022-12-18ea99ee380514…
2023-01-26 05:58 UTC2023-01N208259-001NC2022-03-123bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N208259-001NCE2022-12-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208259-001NC2022-03-123a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208259-001NCE2022-12-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208259-001NC2022-03-12f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N208259-001NCE2022-12-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208259-001NC2022-03-12e64feba35796…
2022-09-29 23:25 UTC2022-09N208259-001NCE2022-12-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208259-001NC2022-03-12cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208259-001NCE2022-12-18cb3db0bc1861…

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
RocklatanNETARSUDIL AND LATANOPROST OPHTHALMIC SOLUTION, 0.02%/0.005%Alcon Laboratories, Inc.b1d71f41-be06-4a08-94d4-e352198f09c22026-08-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 208259
application number: NDA208259
ndc (product): 70727-529

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70727-529Rocklatannetarsudil and latanoprost ophthalmic solution, 0.02%/0.005%Aerie Pharmaceuticals, Inc.NDACurrent
70727-529Rocklatannetarsudil and latanoprost ophthalmic solution, 0.02%/0.005%Aerie Pharmaceuticals, Inc.NDACurrent
70727-529Rocklatannetarsudil and latanoprost ophthalmic solution, 0.02%/0.005%Aerie Pharmaceuticals, Inc.NDACurrent
70727-529Rocklatannetarsudil and latanoprost ophthalmic solution, 0.02%/0.005%Aerie Pharmaceuticals, Inc.NDACurrent
70727-529Rocklatannetarsudil and latanoprost ophthalmic solution, 0.02%/0.005%Aerie Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81086SUPPL 2025-02-06
80987SUPPL 2025-02-05
63403SUPPL2020-06-02
63401SUPPL2020-06-02
61004ORIG2019-11-20
57996ORIG2019-03-14
57989ORIG2019-03-13