Application 090258

Type: ANDA
Sponsor: HANGZHOU BINJIANG

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALENDRONATE SODIUM	ALENDRONATE SODIUM	TABLET;ORAL	EQ 5MG BASE	No	No
002	ALENDRONATE SODIUM	ALENDRONATE SODIUM	TABLET;ORAL	EQ 10MG BASE	No	No
003	ALENDRONATE SODIUM	ALENDRONATE SODIUM	TABLET;ORAL	EQ 35MG BASE	No	No
004	ALENDRONATE SODIUM	ALENDRONATE SODIUM	TABLET;ORAL	EQ 70MG BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090258-001	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2009-09-24
A090258-002	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2009-09-24
A090258-003	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2009-09-24
A090258-004	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2009-09-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A090258-001	AB
A090258-002	AB
A090258-003	AB
A090258-004	AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090258-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2009-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090258-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2009-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090258-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2009-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090258-004	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2009-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090258-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2009-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090258-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2009-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090258-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2009-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090258-004	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2009-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090258-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2009-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090258-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2009-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090258-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2009-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090258-004	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2009-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090258-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2009-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090258-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2009-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090258-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2009-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090258-004	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2009-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090258-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2009-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090258-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2009-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090258-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2009-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090258-004	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2009-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090258-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2009-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090258-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2009-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090258-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2009-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090258-004	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2009-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090258-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2009-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090258-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2009-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090258-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2009-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090258-004	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2009-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090258-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2009-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090258-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2009-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090258-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2009-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090258-004	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2009-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090258-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2009-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090258-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2009-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090258-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2009-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090258-004	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2009-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090258-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2009-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090258-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2009-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090258-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2009-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090258-004	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2009-09-24	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090258-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090258-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090258-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090258-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090258-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090258-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090258-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090258-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090258-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090258-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090258-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090258-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090258-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090258-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090258-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090258-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090258-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090258-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090258-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090258-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090258-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090258-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090258-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090258-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090258-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090258-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090258-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090258-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090258-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090258-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090258-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090258-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090258-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090258-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090258-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090258-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090258-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090258-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090258-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090258-004	AB	1	`d06236e962d9…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alendronate	ALENDRONATE SODIUM	Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.	a24fd39c-34a7-4de2-9439-781e612189ca	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090258 application number: ANDA090258 ndc (product): 60723-207 ndc (product): 60723-205
Alendronate	ALENDRONATE SODIUM TABLET	Marlex Pharmaceuticals, Inc.	b63421af-ec03-1de7-e053-2a95a90abec6	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090258 application number: ANDA090258 ndc (product): 10135-719 ndc (product): 10135-718

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 43 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10135-696	Alendronate	Alendronate Sodium	Marlex Pharmaceuticals Inc	ANDA	Current
10135-697	Alendronate	Alendronate Sodium	Marlex Pharmaceuticals Inc	ANDA	Current
10135-718	Alendronate	Alendronate sodium tablet	Marlex Pharmaceuticals, Inc.	ANDA	Current
10135-718	Alendronate	Alendronate sodium tablet	Marlex Pharmaceuticals, Inc.	ANDA	Current
10135-718	Alendronate	Alendronate sodium tablet	Marlex Pharmaceuticals, Inc.	ANDA	Current
10135-719	Alendronate	Alendronate sodium tablet	Marlex Pharmaceuticals, Inc.	ANDA	Current
10135-719	Alendronate	Alendronate sodium tablet	Marlex Pharmaceuticals, Inc.	ANDA	Current
10135-719	Alendronate	Alendronate sodium tablet	Marlex Pharmaceuticals, Inc.	ANDA	Current
50090-2587	Alendronate	ALENDRONATE SODIUM	A-S Medication Solutions	ANDA	Current
50090-3593	Alendronate	ALENDRONATE SODIUM	A-S Medication Solutions	ANDA	Current
50090-3593	Alendronate	ALENDRONATE SODIUM	A-S Medication Solutions	ANDA	Current
60429-055	Alendronate Sodium	Alendronate Sodium	Golden State Medical Supply, Inc.	ANDA	Current
60429-055	Alendronate Sodium	Alendronate Sodium	Golden State Medical Supply, Inc.	ANDA	Current
60429-056	Alendronate Sodium	Alendronate Sodium	Golden State Medical Supply, Inc.	ANDA	Current
60429-056	Alendronate Sodium	Alendronate Sodium	Golden State Medical Supply, Inc.	ANDA	Current
60723-205	Alendronate	ALENDRONATE SODIUM	Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.	ANDA	Current
60723-205	Alendronate	ALENDRONATE SODIUM	Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.	ANDA	Current
60723-205	Alendronate	ALENDRONATE SODIUM	Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.	ANDA	Current
60723-205	Alendronate	ALENDRONATE SODIUM	Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.	ANDA	Current
60723-205	Alendronate	ALENDRONATE SODIUM	Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.	ANDA	Current
60723-207	Alendronate	ALENDRONATE SODIUM	Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.	ANDA	Current
60723-207	Alendronate	ALENDRONATE SODIUM	Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.	ANDA	Current
60723-207	Alendronate	ALENDRONATE SODIUM	Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.	ANDA	Current
60723-207	Alendronate	ALENDRONATE SODIUM	Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.	ANDA	Current
60723-207	Alendronate	ALENDRONATE SODIUM	Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.	ANDA	Current
63629-7329	Alendronate	ALENDRONATE SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-7329	Alendronate	ALENDRONATE SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-7329	Alendronate	ALENDRONATE SODIUM	Bryant Ranch Prepack	ANDA	Current
68071-4017	Alendronate	ALENDRONATE SODIUM	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4017	Alendronate	ALENDRONATE SODIUM	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4072	Alendronate	ALENDRONATE SODIUM	NuCare Pharmaceuticals,Inc.	ANDA	Current
69543-130	Alendronate	ALENDRONATE SODIUM	Virtus Pharmaceuticals	ANDA	Current
69543-130	Alendronate	ALENDRONATE SODIUM	Virtus Pharmaceuticals	ANDA	Current
69543-130	Alendronate	ALENDRONATE SODIUM	Virtus Pharmaceuticals	ANDA	Current
69543-130	Alendronate	ALENDRONATE SODIUM	Virtus Pharmaceuticals	ANDA	Current
69543-130	Alendronate	ALENDRONATE SODIUM	Virtus Pharmaceuticals	ANDA	Current
69543-130	Alendronate	ALENDRONATE SODIUM	Virtus Pharmaceuticals	ANDA	Current
69543-131	Alendronate	ALENDRONATE SODIUM	Virtus Pharmaceuticals	ANDA	Current
69543-131	Alendronate	ALENDRONATE SODIUM	Virtus Pharmaceuticals	ANDA	Current
69543-131	Alendronate	ALENDRONATE SODIUM	Virtus Pharmaceuticals	ANDA	Current
69543-131	Alendronate	ALENDRONATE SODIUM	Virtus Pharmaceuticals	ANDA	Current
69543-131	Alendronate	ALENDRONATE SODIUM	Virtus Pharmaceuticals	ANDA	Current
69543-131	Alendronate	ALENDRONATE SODIUM	Virtus Pharmaceuticals	ANDA	Current