Application 076984

Type: ANDA
Sponsor: WATSON LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALENDRONATE SODIUM	ALENDRONATE SODIUM	TABLET;ORAL	EQ 35MG BASE	No	No
002	ALENDRONATE SODIUM	ALENDRONATE SODIUM	TABLET;ORAL	EQ 40MG 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
A076984-001	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04
A076984-002	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04
A076984-003	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
A076984-001	AB
A076984-002	AB
A076984-003	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	A076984-001	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076984-002	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076984-003	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	A076984-001	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	A076984-002	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076984-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076984-001	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076984-002	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076984-003	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	A076984-001	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	A076984-002	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076984-003	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	A076984-001	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	A076984-002	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076984-003	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	A076984-001	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	A076984-002	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076984-003	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	A076984-001	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	A076984-002	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076984-003	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	A076984-001	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	A076984-002	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076984-003	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	A076984-001	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	A076984-002	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076984-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076984-001	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076984-002	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076984-003	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	A076984-001	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	A076984-002	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076984-003	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	A076984-001	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	A076984-002	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076984-003	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	A076984-001	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	A076984-002	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076984-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076984-001	ALENDRONATE SODIUM	EQ 35MG 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	A076984-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076984-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076984-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076984-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076984-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076984-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076984-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076984-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076984-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076984-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076984-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076984-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076984-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076984-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076984-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076984-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076984-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076984-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076984-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076984-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076984-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076984-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076984-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076984-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076984-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076984-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076984-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076984-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076984-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076984-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076984-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076984-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076984-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076984-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076984-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076984-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076984-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076984-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076984-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076984-001	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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALENDRONATE SODIUM	ALENDRONATE SODIUM	REMEDYREPACK INC.	c7e470d6-508e-466e-a78d-060bbbc9745c	2026-07-03	Warnings, Adverse reactions	Name fallback brand name: ALENDRONATE SODIUM generic name: ALENDRONATE SODIUM
ALENDRONATE SODIUM	ALENDRONATE SODIUM	NuCare Pharmaceuticals,Inc.	54d6543d-4239-58b1-e054-00144ff88e88	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: ALENDRONATE SODIUM generic name: ALENDRONATE SODIUM
ALENDRONATE SODIUM	ALENDRONATE SODIUM	REMEDYREPACK INC.	c4358ba7-1bf8-4b0a-9407-5ac279d04555	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: ALENDRONATE SODIUM generic name: ALENDRONATE SODIUM
Alendronate Sodium	ALENDRONATE SODIUM	Rising Pharma Holdings, Inc.	ffdd2496-d253-419b-85a6-8c615f7545f1	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Alendronate Sodium generic name: ALENDRONATE SODIUM
Alendronate Sodium	ALENDRONATE SODIUM	NorthStar Rx LLC	4323d3aa-cbb0-41e2-aba7-7a94a0516993	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Alendronate Sodium generic name: ALENDRONATE SODIUM
Alendronate Sodium	ALENDRONATE SODIUM	A-S Medication Solutions	d52cf007-5775-4dea-9f43-b1907b6ffe81	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: Alendronate Sodium generic name: ALENDRONATE SODIUM
Alendronate Sodium	ALENDRONATE SODIUM	Aurobindo Pharma Limited	815a87c4-e489-4eb9-9a2e-fb7a16642f01	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Alendronate Sodium generic name: ALENDRONATE SODIUM
ALENDRONATE SODIUM	ALENDRONATE SODIUM	Cipla USA Inc.	e2fac28d-ad91-4cdc-a003-9fdeac073f76	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: ALENDRONATE SODIUM generic name: ALENDRONATE SODIUM
FOSAMAX	ALENDRONATE SODIUM	Organon LLC	14e931fd-2c5f-4d90-b7db-5980706f4a56	2026-03-12	Warnings, Adverse reactions	Name fallback generic name: ALENDRONATE SODIUM
ALENDRONATE SODIUM	ALENDRONATE SODIUM	Preferred Pharmaceuticals Inc.	83e3ba94-d882-4b5c-87cb-af1eb0997efc	2026-02-16	Warnings, Adverse reactions	Name fallback brand name: ALENDRONATE SODIUM generic name: ALENDRONATE SODIUM
Alendronate Sodium	ALENDRONATE SODIUM	A-S Medication Solutions	eeb65442-6b3c-485c-9c5d-9cf40df4451e	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: Alendronate Sodium generic name: ALENDRONATE SODIUM
Binosto	ALENDRONATE SODIUM	Radius Health, Inc.	09765234-01bc-40f7-b9bb-c167056f3909	2026-02-06	Warnings, Adverse reactions	Name fallback generic name: ALENDRONATE SODIUM
Alendronate Sodium	ALENDRONATE SODIUM	Hikma Pharmaceuticals USA Inc.	c910bb05-279b-4ffa-a867-46f4a0853ed5	2026-01-15	Warnings, Adverse reactions	Name fallback brand name: Alendronate Sodium generic name: ALENDRONATE SODIUM
Alendronate	ALENDRONATE SODIUM	Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.	a24fd39c-34a7-4de2-9439-781e612189ca	2025-12-16	Warnings, Adverse reactions	Name fallback generic name: ALENDRONATE SODIUM
ALENDRONATE SODIUM	ALENDRONATE SODIUM	A-S Medication Solutions	fe1dd324-eb02-4a73-97f5-9b77a7df10a7	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: ALENDRONATE SODIUM generic name: ALENDRONATE SODIUM
Alendronate Sodium	ALENDRONATE SODIUM	ANI Pharmaceuticals, Inc.	81589178-10c9-4806-91eb-54e638d35b8d	2025-10-29	Warnings, Adverse reactions	Name fallback brand name: Alendronate Sodium generic name: ALENDRONATE SODIUM
ALENDRONATE SODIUM	ALENDRONATE SODIUM	NuCare Pharmaceuticals, Inc.	2baf8516-4148-9007-e063-6394a90a8094	2025-01-14	Warnings, Adverse reactions	Name fallback brand name: ALENDRONATE SODIUM generic name: ALENDRONATE SODIUM
Alendronate Sodium	ALENDRONATE SODIUM	A-S Medication Solutions	873442b0-1932-4fa6-ba25-b4d3505f4128	2024-11-13	Warnings, Adverse reactions	Name fallback brand name: Alendronate Sodium generic name: ALENDRONATE SODIUM
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EXELAN PHARMACEUTICALS INC.	91a0f73a-d8cd-4197-b431-40707a2150b9	2023-08-25	Warnings, Adverse reactions	Name fallback brand name: ALENDRONATE SODIUM generic name: ALENDRONATE SODIUM
Alendronate Sodium	ALENDRONATE SODIUM	Proficient Rx LP	6c4d13fb-490c-4ea9-9b04-003c8d8e9f0c	2023-03-01	Warnings, Adverse reactions	Name fallback brand name: Alendronate Sodium generic name: ALENDRONATE SODIUM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16252-599	alendronate sodium	alendronate sodium	Actavis Pharma, Inc.	ANDA	Current
16252-601	alendronate sodium	alendronate sodium	Actavis Pharma, Inc.	ANDA	Current
50090-1091	alendronate sodium	alendronate sodium	A-S Medication Solutions	ANDA	Current
53217-321	alendronate sodium	alendronate sodium	Aidarex Pharmaceuticals LLC	ANDA	Current
55695-012	alendronate sodium	alendronate sodium	Department of State Health Services, Pharmacy Branch	ANDA	Current
63187-580	alendronate sodium	alendronate sodium	Proficient Rx LP	ANDA	Current
68071-4120	alendronate sodium	alendronate sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68258-3014	Alendronate Sodium	alendronate sodium	Dispensing Solutions Inc.	ANDA	Current
70518-0269	alendronate sodium	alendronate sodium	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23844	ORIG	2008-09-19