Home Applications 076984 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 43 .
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 RLD / RS 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.
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 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A076984-001 ALENDRONATE SODIUM EQ 35MG BASE TABLET / ORAL AB 2008-08-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076984-002 ALENDRONATE SODIUM EQ 40MG BASE TABLET / ORAL AB 2008-08-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076984-003 ALENDRONATE SODIUM EQ 70MG BASE TABLET / ORAL AB 2008-08-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076984-001 ALENDRONATE SODIUM EQ 35MG BASE TABLET / ORAL AB 2008-08-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076984-002 ALENDRONATE SODIUM EQ 40MG BASE TABLET / ORAL AB 2008-08-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076984-003 ALENDRONATE SODIUM EQ 70MG BASE TABLET / ORAL AB 2008-08-04 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
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 2 of 2 · 21 matching rows.
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 · 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