Application 090124

Type: ANDA
Sponsor: AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALENDRONATE SODIUM	ALENDRONATE SODIUM	TABLET;ORAL	EQ 10MG BASE	No	No
002	ALENDRONATE SODIUM	ALENDRONATE SODIUM	TABLET;ORAL	EQ 35MG BASE	No	No
003	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090124-001	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04
A090124-002	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04
A090124-003	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090124-001	AB
A090124-002	AB
A090124-003	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 4 · 123 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	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A090124-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090124-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090124-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090124-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090124-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090124-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090124-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090124-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090124-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090124-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090124-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090124-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090124-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090124-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090124-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090124-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090124-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090124-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090124-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090124-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090124-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090124-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090124-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090124-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090124-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090124-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090124-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090124-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090124-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090124-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090124-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090124-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090124-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090124-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090124-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090124-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090124-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090124-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090124-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090124-001	AB	1	`8072bd15b7f6…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alendronate Sodium	ALENDRONATE SODIUM	Rising Pharma Holdings, Inc.	ffdd2496-d253-419b-85a6-8c615f7545f1	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090124 application number: ANDA090124 ndc (product): 64980-340 ndc (product): 64980-341 ndc (product): 64980-342
Alendronate Sodium	ALENDRONATE SODIUM	NorthStar Rx LLC	4323d3aa-cbb0-41e2-aba7-7a94a0516993	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090124 application number: ANDA090124 ndc (product): 16714-632 ndc (product): 16714-631 ndc (product): 16714-633
Alendronate Sodium	ALENDRONATE SODIUM	A-S Medication Solutions	d52cf007-5775-4dea-9f43-b1907b6ffe81	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090124 application number: ANDA090124 ndc (product): 50090-3126
Alendronate Sodium	ALENDRONATE SODIUM	Aurobindo Pharma Limited	815a87c4-e489-4eb9-9a2e-fb7a16642f01	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090124 application number: ANDA090124 ndc (product): 65862-328 ndc (product): 65862-329 ndc (product): 65862-327
Alendronate Sodium	ALENDRONATE SODIUM	A-S Medication Solutions	eeb65442-6b3c-485c-9c5d-9cf40df4451e	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090124 application number: ANDA090124 ndc (product): 50090-5677
Alendronate Sodium	ALENDRONATE SODIUM	A-S Medication Solutions	873442b0-1932-4fa6-ba25-b4d3505f4128	2024-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090124 application number: ANDA090124 ndc (product): 50090-5474
Alendronate Sodium	ALENDRONATE SODIUM	Proficient Rx LP	6c4d13fb-490c-4ea9-9b04-003c8d8e9f0c	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090124 application number: ANDA090124 ndc (product): 71205-048

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-631	Alendronate Sodium	Alendronate Sodium	NorthStar Rx LLC	ANDA	Current
16714-631	Alendronate Sodium	Alendronate Sodium	NorthStar Rx LLC	ANDA	Current
16714-631	Alendronate Sodium	Alendronate Sodium	NorthStar Rx LLC	ANDA	Current
16714-632	Alendronate Sodium	Alendronate Sodium	NorthStar Rx LLC	ANDA	Current
16714-632	Alendronate Sodium	Alendronate Sodium	NorthStar Rx LLC	ANDA	Current
16714-632	Alendronate Sodium	Alendronate Sodium	NorthStar Rx LLC	ANDA	Current
16714-633	Alendronate Sodium	Alendronate Sodium	NorthStar Rx LLC	ANDA	Current
16714-633	Alendronate Sodium	Alendronate Sodium	NorthStar Rx LLC	ANDA	Current
16714-633	Alendronate Sodium	Alendronate Sodium	NorthStar Rx LLC	ANDA	Current
50090-2322	Alendronate Sodium	Alendronate Sodium	A-S Medication Solutions	ANDA	Current
50090-2322	Alendronate Sodium	Alendronate Sodium	A-S Medication Solutions	ANDA	Current
50090-2322	Alendronate Sodium	Alendronate Sodium	A-S Medication Solutions	ANDA	Current
50090-2322	Alendronate Sodium	Alendronate Sodium	A-S Medication Solutions	ANDA	Current
50090-3126	Alendronate Sodium	Alendronate Sodium	A-S Medication Solutions	ANDA	Current
50090-3126	Alendronate Sodium	Alendronate Sodium	A-S Medication Solutions	ANDA	Current
50090-3126	Alendronate Sodium	Alendronate Sodium	A-S Medication Solutions	ANDA	Current
50090-5474	Alendronate Sodium	Alendronate Sodium	A-S Medication Solutions	ANDA	Current
50090-5677	Alendronate Sodium	Alendronate Sodium	A-S Medication Solutions	ANDA	Current
50090-5677	Alendronate Sodium	Alendronate Sodium	A-S Medication Solutions	ANDA	Current
64980-340	Alendronate Sodium	Alendronate Sodium	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-340	Alendronate Sodium	Alendronate Sodium	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-340	Alendronate Sodium	Alendronate Sodium	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-341	Alendronate Sodium	Alendronate Sodium	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-341	Alendronate Sodium	Alendronate Sodium	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-341	Alendronate Sodium	Alendronate Sodium	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-342	Alendronate Sodium	Alendronate Sodium	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-342	Alendronate Sodium	Alendronate Sodium	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-342	Alendronate Sodium	Alendronate Sodium	Rising Pharmaceuticals, Inc.	ANDA	Current
65862-327	Alendronate Sodium	Alendronate Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-327	Alendronate Sodium	Alendronate Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-327	Alendronate Sodium	Alendronate Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-327	Alendronate Sodium	Alendronate Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-328	Alendronate Sodium	Alendronate Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-328	Alendronate Sodium	Alendronate Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-328	Alendronate Sodium	Alendronate Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-328	Alendronate Sodium	Alendronate Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-329	Alendronate Sodium	Alendronate Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-329	Alendronate Sodium	Alendronate Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-329	Alendronate Sodium	Alendronate Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-329	Alendronate Sodium	Alendronate Sodium	Aurobindo Pharma Limited	ANDA	Current
68071-1514	Alendronate Sodium	Alendronate Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1514	Alendronate Sodium	Alendronate Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8235	Alendronate Sodium	Alendronate Sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
71205-048	Alendronate Sodium	Alendronate Sodium	Proficient Rx LP	ANDA	Current
71205-048	Alendronate Sodium	Alendronate Sodium	Proficient Rx LP	ANDA	Current
71205-048	Alendronate Sodium	Alendronate Sodium	Proficient Rx LP	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44415	ORIG	2008-09-19