Application 078208

Type: ANDA
Sponsor: ALTAIRE PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE	SOLUTION/DROPS;OPHTHALMIC	0.02675%;0.315%	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC			2010-09-27

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078208-001	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	2010-09-27	`cb3db0bc1861…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naphazoline HCI And Pheniramine Maleate	NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE	Altaire Pharmaceuticals Inc.	5649c6e2-966f-44d9-b57e-5bb988eb373d	2020-12-28	Warnings	Exact identifier application applno (ANDA): 078208 application number: ANDA078208 ndc (product): 59390-177

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49035-874	Equate Eye Allergy Relief Drops	NAPHAZOLINE HYDROCHLORIDE, Pheniramine Maleate	Wal-Mart Stores, Inc.	ANDA	Current
59390-177	Naphazoline HCI And Pheniramine Maleate	NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE	Altaire Pharmaceuticals Inc.	ANDA	Current
59390-177	Naphazoline HCI And Pheniramine Maleate	NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE	Altaire Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43136	ORIG	2013-01-30