Application 076768

Type
ANDA
Sponsor
CIPLA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALENDRONATE SODIUMALENDRONATE SODIUMTABLET;ORALEQ 5MG BASENoNo
002ALENDRONATE SODIUMALENDRONATE SODIUMTABLET;ORALEQ 10MG BASENoNo
003ALENDRONATE SODIUMALENDRONATE SODIUMTABLET;ORALEQ 35MG BASENoNo
004ALENDRONATE SODIUMALENDRONATE SODIUMTABLET;ORALEQ 40MG BASENoNo
005ALENDRONATE SODIUMALENDRONATE SODIUMTABLET;ORALEQ 70MG BASENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076768-001ALENDRONATE SODIUMALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2008-08-04
A076768-002ALENDRONATE SODIUMALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-04
A076768-003ALENDRONATE SODIUMALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-04
A076768-004ALENDRONATE SODIUMALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-04
A076768-005ALENDRONATE SODIUMALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A076768-001AB
A076768-002AB
A076768-003AB
A076768-004AB
A076768-005AB

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 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076768-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2008-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076768-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076768-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076768-004ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076768-005ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076768-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2008-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076768-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076768-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076768-004ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076768-005ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A076768-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2008-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076768-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076768-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076768-004ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076768-005ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076768-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2008-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076768-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076768-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076768-004ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076768-005ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076768-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2008-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076768-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076768-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076768-004ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076768-005ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076768-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2008-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076768-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076768-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076768-004ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076768-005ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076768-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2008-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076768-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076768-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076768-004ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076768-005ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076768-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2008-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076768-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076768-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076768-004ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076768-005ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-045bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076768-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076768-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076768-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076768-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076768-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076768-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076768-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076768-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076768-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076768-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076768-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076768-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076768-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076768-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076768-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076768-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076768-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076768-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076768-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076768-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076768-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076768-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076768-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076768-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076768-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076768-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076768-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076768-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076768-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076768-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076768-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076768-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076768-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076768-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076768-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076768-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076768-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076768-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076768-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076768-005AB15bbf6a4d5a75…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALENDRONATE SODIUMALENDRONATE SODIUMREMEDYREPACK INC.c7e470d6-508e-466e-a78d-060bbbc9745c2026-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076768
application number: ANDA076768
ALENDRONATE SODIUMALENDRONATE SODIUMNuCare Pharmaceuticals,Inc.54d6543d-4239-58b1-e054-00144ff88e882026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076768
application number: ANDA076768
ndc (product): 68071-3340
ALENDRONATE SODIUMALENDRONATE SODIUMREMEDYREPACK INC.c4358ba7-1bf8-4b0a-9407-5ac279d045552026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076768
application number: ANDA076768
ndc (product): 70518-0033
ALENDRONATE SODIUMALENDRONATE SODIUMCipla USA Inc.e2fac28d-ad91-4cdc-a003-9fdeac073f762026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076768
application number: ANDA076768
ndc (product): 69097-224
ndc (product): 69097-223
ALENDRONATE SODIUMALENDRONATE SODIUMPreferred Pharmaceuticals Inc.83e3ba94-d882-4b5c-87cb-af1eb0997efc2026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076768
application number: ANDA076768
ndc (product): 68788-7130
ALENDRONATE SODIUMALENDRONATE SODIUMA-S Medication Solutionsfe1dd324-eb02-4a73-97f5-9b77a7df10a72025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076768
application number: ANDA076768
ndc (product): 50090-4692
ALENDRONATE SODIUMALENDRONATE SODIUMNuCare Pharmaceuticals, Inc.2baf8516-4148-9007-e063-6394a90a80942025-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076768
application number: ANDA076768
ALENDRONATE SODIUMALENDRONATE SODIUMEXELAN PHARMACEUTICALS INC.91a0f73a-d8cd-4197-b431-40707a2150b92023-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076768
application number: ANDA076768
ndc (product): 76282-682
ndc (product): 76282-681

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-901Alendronate Sodiumalendronate sodiumRebel Distributors CorpANDACurrent
21695-902Alendronate Sodiumalendronate sodiumRebel Distributors CorpANDACurrent
50090-4076ALENDRONATE SODIUMAlendronate sodiumA-S Medication SolutionsANDACurrent
50090-4076ALENDRONATE SODIUMAlendronate sodiumA-S Medication SolutionsANDACurrent
50090-4692ALENDRONATE SODIUMAlendronate sodiumA-S Medication SolutionsANDACurrent
50090-4692ALENDRONATE SODIUMAlendronate sodiumA-S Medication SolutionsANDACurrent
50090-4692ALENDRONATE SODIUMAlendronate sodiumA-S Medication SolutionsANDACurrent
50090-4692ALENDRONATE SODIUMAlendronate sodiumA-S Medication SolutionsANDACurrent
61919-689ALENDRONATE SODIUMALENDRONATE SODIUMDIRECT RXANDACurrent
61919-729Alendronate SodiumAlendronate SodiumDirect_RxANDACurrent
68071-3171ALENDRONATE SODIUMAlendronate sodiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3171ALENDRONATE SODIUMAlendronate sodiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3171ALENDRONATE SODIUMAlendronate sodiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3340ALENDRONATE SODIUMAlendronate sodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3340ALENDRONATE SODIUMAlendronate sodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3340ALENDRONATE SODIUMAlendronate sodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7130ALENDRONATE SODIUMAlendronate sodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7130ALENDRONATE SODIUMAlendronate sodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7130ALENDRONATE SODIUMAlendronate sodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7130ALENDRONATE SODIUMAlendronate sodiumPreferred Pharmaceuticals Inc.ANDACurrent
69097-223ALENDRONATE SODIUMAlendronate sodiumCipla USA Inc.ANDACurrent
69097-223ALENDRONATE SODIUMAlendronate sodiumCipla USA Inc.ANDACurrent
69097-223ALENDRONATE SODIUMAlendronate sodiumCipla USA Inc.ANDACurrent
69097-224ALENDRONATE SODIUMAlendronate sodiumCipla USA Inc.ANDACurrent
69097-224ALENDRONATE SODIUMAlendronate sodiumCipla USA Inc.ANDACurrent
69097-224ALENDRONATE SODIUMAlendronate sodiumCipla USA Inc.ANDACurrent
70518-0033ALENDRONATE SODIUMAlendronate sodiumREMEDYREPACK INC.ANDACurrent
70518-0033ALENDRONATE SODIUMAlendronate sodiumREMEDYREPACK INC.ANDACurrent
70518-0033ALENDRONATE SODIUMAlendronate sodiumREMEDYREPACK INC.ANDACurrent
70518-0033ALENDRONATE SODIUMAlendronate sodiumREMEDYREPACK INC.ANDACurrent
70518-0033ALENDRONATE SODIUMAlendronate sodiumREMEDYREPACK INC.ANDACurrent
70518-0033ALENDRONATE SODIUMAlendronate sodiumREMEDYREPACK INC.ANDACurrent
70518-0033ALENDRONATE SODIUMAlendronate sodiumREMEDYREPACK INC.ANDACurrent
70518-0033ALENDRONATE SODIUMAlendronate sodiumREMEDYREPACK INC.ANDACurrent
70518-0033ALENDRONATE SODIUMAlendronate sodiumREMEDYREPACK INC.ANDACurrent
70518-0033ALENDRONATE SODIUMAlendronate sodiumREMEDYREPACK INC.ANDACurrent
70518-0033ALENDRONATE SODIUMAlendronate sodiumREMEDYREPACK INC.ANDACurrent
76282-681ALENDRONATE SODIUMAlendronate sodiumExelan Pharmaceuticals Inc.ANDACurrent
76282-682ALENDRONATE SODIUMAlendronate sodiumExelan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44320ORIG2008-09-19