FDA.reportPublic FDA data

Application 202795

Type
ANDA
Sponsor
AKORN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATENAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATESOLUTION/DROPS;OPHTHALMIC0.025%;0.3%NoNo

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
A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATENAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-24

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 22:38:342026-08A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-2484e616aacf4f…
2026-08-18 06:07:402026-07A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-243f01610625f2…
2019-09-15 20:21 UTC2019-09A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202795-001NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMIC2013-01-24f41ea6bd6efb…

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-9650Naphazoline Hydrochloride and Pheniramine MaleateNaphazoline hydrochloride and Pheniramine MaleateWalgreensANDACurrent
17478-065Naphazoline Hydrochloride and Pheniramine MaleateNaphazoline Hydrochloride and Pheniramine MaleateAkornANDACurrent
17478-065Naphazoline Hydrochloride and Pheniramine MaleateNaphazoline Hydrochloride and Pheniramine MaleateAkorn, Inc.ANDACurrent
17478-065Naphazoline Hydrochloride and Pheniramine MaleateNaphazoline Hydrochloride and Pheniramine MaleateAkorn, Inc.ANDACurrent
59779-365Naphazoline Hydrochloride and Pheniramine MaleateNaphazoline hydrochloride and Pheniramine MaleateCVS PharmacyANDACurrent
59779-366ALLERGY EYE DROPSNaphazoline hydrochloride and Pheniramine MaleateCVS PharmacyANDACurrent
68016-450Allergy Eye DropsNaphazoline hydrochloride and Pheniramine MaleateChain Drug ConsortiumANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32304ORIG2013-01-25