Application 090162

Type
ANDA
Sponsor
UNICHEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOPIRAMATETOPIRAMATETABLET;ORAL25MGNoNo
002TOPIRAMATETOPIRAMATETABLET;ORAL50MGNoNo
003TOPIRAMATETOPIRAMATETABLET;ORAL100MGNoNo
004TOPIRAMATETOPIRAMATETABLET;ORAL200MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090162-001TOPIRAMATETOPIRAMATE25MGTABLET / ORALAB2009-03-27
A090162-002TOPIRAMATETOPIRAMATE50MGTABLET / ORALAB2009-03-27
A090162-003TOPIRAMATETOPIRAMATE100MGTABLET / ORALAB2009-03-27
A090162-004TOPIRAMATETOPIRAMATE200MGTABLET / ORALAB2013-02-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090162-001AB
A090162-002AB
A090162-003AB
A090162-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090162-004TOPIRAMATE200MGTABLET / ORALAB2013-02-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090162-004TOPIRAMATE200MGTABLET / ORALAB2013-02-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A090162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090162-004TOPIRAMATE200MGTABLET / ORALAB2013-02-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090162-004TOPIRAMATE200MGTABLET / ORALAB2013-02-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090162-004TOPIRAMATE200MGTABLET / ORALAB2013-02-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090162-004TOPIRAMATE200MGTABLET / ORALAB2013-02-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090162-004TOPIRAMATE200MGTABLET / ORALAB2013-02-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090162-004TOPIRAMATE200MGTABLET / ORALAB2013-02-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090162-004TOPIRAMATE200MGTABLET / ORALAB2013-02-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A090162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A090162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A090162-004TOPIRAMATE200MGTABLET / ORALAB2013-02-19d06236e962d9…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090162-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090162-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090162-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090162-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090162-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090162-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090162-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090162-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090162-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090162-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090162-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090162-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090162-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090162-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090162-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090162-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090162-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090162-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090162-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090162-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090162-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090162-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090162-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090162-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090162-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090162-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090162-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090162-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090162-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090162-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090162-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090162-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090162-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090162-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090162-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090162-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090162-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090162-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090162-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090162-004AB1d06236e962d9…

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 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
topiramateTOPIRAMATESt. Mary's Medical Park Pharmacy46a305cb-ab73-0bca-e063-6294a90a9b852026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEBryant Ranch Prepack12cd9be8-c5c2-4a16-9164-87963e22a88e2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATECoupler LLC52ba9c4f-e7d0-4352-e063-6394a90af7e22026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATECoupler LLC50b10a3d-883c-8891-e063-6394a90a86a12026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEUnichem Pharmaceuticals (USA), Inc.6ee00e82-799d-445e-b658-a9712c49a28e2026-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
ndc (product): 29300-118
ndc (product): 29300-117
ndc (product): 29300-115
ndc (product): 29300-116
topiramateTOPIRAMATEREMEDYREPACK INC.be14624b-7eb9-4e7a-9274-1bb88270ecbe2026-03-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEAdvanced Rx of Tennessee, LLC4b1d3130-cf3c-d7da-e063-6294a90a60792026-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEPreferred Pharmaceuticals Inc.68b22d22-c2d3-4e90-b302-56f7cb7314272026-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEA-S Medication Solutionsa5cffe7a-fdee-487a-bafb-a2d43e76c23c2025-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
ndc (product): 50090-2248
ndc (product): 50090-2203
ndc (product): 50090-2102
topiramateTOPIRAMATEA-S Medication Solutionsc6918801-f22c-4ba4-a396-da484d4334ca2025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEBryant Ranch Prepack49701840-5a32-4ac1-8b07-5c61decacb952025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEBryant Ranch Prepackbf732c34-9078-496a-8093-f68594e76fcb2025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEBryant Ranch Prepack02cac021-e135-483f-bb5d-f3696eef06822025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEBryant Ranch Prepackc320999e-b940-44d8-bf31-2fb78835ac2d2025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEBryant Ranch Prepack073d075d-d019-4834-b55d-9b95879149752025-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
ndc (product): 71335-1064
topiramateTOPIRAMATEAdvanced Rx of Tennessee, LLC30ca2fce-4e4c-439e-e063-6294a90af0762025-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEPreferred Pharmaceuticals Inc.bbf0f882-1dcc-415d-82bb-acc64f4dc2bc2025-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEPreferred Pharmaceuticals Inc.288d6b40-8c87-4f16-85a7-86166b5ac77f2025-02-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEAdvanced Rx of Tennessee, LLC2cf7ce9e-afc2-f94e-e063-6394a90a35d02025-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEPreferred Pharmaceuticals Inc.521be3f1-3ee7-45c7-9f0c-17e08b6c8fca2025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 57 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
29300-115topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-115topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-115topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-115topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-115topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-115topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-116topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-116topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-116topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-116topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-116topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-116topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-117topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-117topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-117topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-117topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-117topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-117topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-118topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-118topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-118topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-118topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-118topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-118topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
50090-2102topiramatetopiramateA-S Medication SolutionsANDACurrent
50090-2102topiramatetopiramateA-S Medication SolutionsANDACurrent
50090-2203topiramatetopiramateA-S Medication SolutionsANDACurrent
50090-2203topiramatetopiramateA-S Medication SolutionsANDACurrent
50090-2248topiramatetopiramateA-S Medication SolutionsANDACurrent
50090-2248topiramatetopiramateA-S Medication SolutionsANDACurrent
53808-1131topiramatetopiramateDOH CENTRAL PHARMACYANDACurrent
54569-6137topiramatetopiramateA-S Medication SolutionsANDACurrent
61919-189TOPAMAXTOPIRAMATEDIRECT RXANDACurrent
68071-4760topiramatetopiramateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4760topiramatetopiramateNuCare Pharmaceuticals,Inc.ANDACurrent
70518-1853topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1853topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2322topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2322topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2322topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2322topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2322topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2498topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2498topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2498topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2498topiramatetopiramateREMEDYREPACK INC.ANDACurrent
71205-187topiramatetopiramateProficient Rx LPANDACurrent
71205-187topiramatetopiramateProficient Rx LPANDACurrent
71205-187topiramatetopiramateProficient Rx LPANDACurrent
71205-195topiramatetopiramateProficient Rx LPANDACurrent
71205-195topiramatetopiramateProficient Rx LPANDACurrent
71205-195topiramatetopiramateProficient Rx LPANDACurrent
71205-202topiramatetopiramateProficient Rx LPANDACurrent
71205-202topiramatetopiramateProficient Rx LPANDACurrent
71335-1064topiramatetopiramateBryant Ranch PrepackANDACurrent
71335-1064topiramatetopiramateBryant Ranch PrepackANDACurrent
71335-1064topiramatetopiramateBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23938ORIG2009-04-14