Application 090705

Type
ANDA
Sponsor
INVAGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GABAPENTINGABAPENTINCAPSULE;ORAL100MGNoNo
002GABAPENTINGABAPENTINCAPSULE;ORAL300MGNoNo
003GABAPENTINGABAPENTINCAPSULE;ORAL400MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090705-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2009-12-30
A090705-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2009-12-30
A090705-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2009-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090705-001AB
A090705-002AB
A090705-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-308072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090705-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090705-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090705-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090705-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090705-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090705-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090705-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090705-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090705-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090705-001AB18072bd15b7f6…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINDIRECT RX29a70e2d-d3fd-4e32-95dd-7ee721d873882026-01-08Warnings, Adverse reactionsExact identifier
ndc (product): 61919-982
GABAPENTINGABAPENTINREMEDYREPACK INC.1373587e-807a-462a-bff6-8a7113ce9f0a2025-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINExelan Pharmaceuticals, Inc.41d1ead3-046e-4abf-ae0a-cb126a1f58482025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINCipla USA Inc.9e4eca9c-6a2c-4ede-a252-1a27094bf5942025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINBryant Ranch Prepack6e7f602a-2c5f-4651-a228-5fc5bf2492052024-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINBryant Ranch Prepack1fd95278-842f-4bf9-abd5-4d9aa858d36d2024-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINBryant Ranch Prepack97a1d45d-d5b3-4be7-9b3a-cb6f80f602912024-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINAsclemed USA, Inc.45039bba-7a96-450c-95be-83a3aa4fcbd22020-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINProficient Rx LP4bae5032-f634-4d1e-b672-8a7e2bd6a5fa2019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
ndc (product): 63187-392
GABAPENTINGABAPENTINProficient Rx LP92c4d589-533b-4fe4-833f-dd68cc1f7e662019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
ndc (product): 63187-909
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLCa900bafb-8f49-4a01-ba7f-4fb228ec02532018-11-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLC6702ed8f-4aaf-46fa-bf39-db75154aa44c2018-10-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 126 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-011GabapentinGabapentinBlenheim Pharmacal, Inc.ANDACurrent
10544-557GabapentinGabapentinBlenheim Pharmacal, Inc.ANDACurrent
31722-221GabapentinGabapentinCamber Pharmaceuticals Inc.ANDACurrent
31722-222GabapentinGabapentinCamber Pharmaceuticals Inc.ANDACurrent
31722-223GabapentinGabapentinCamber Pharmaceuticals Inc.ANDACurrent
35356-727GabapentinGabapentinLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
42254-049GabapentinGabapentinRebel Distributors CorpANDACurrent
43353-709GabapentinGabapentinAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
43353-710GabapentinGabapentinAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
43353-731GabapentinGabapentinAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
45861-011GabapentinGabapentinPharmaceutica North America, Inc.ANDACurrent
45861-100Gabapentin KitGABAPENTINPharmaceutica North America, Inc.ANDACurrent
45865-498GabapentinGabapentinMedsource PharmaceuticalsANDACurrent
45865-498GabapentinGabapentinMedsource PharmaceuticalsANDACurrent
50090-1556GabapentinGabapentinA-S Medication SolutionsANDACurrent
50436-0813GABAPENTINGABAPENTINUnit Dose ServicesANDACurrent
50436-1263GabapentinGabapentinUnit Dose ServicesANDACurrent
50436-7285GabapentinGabapentinUnit Dose ServicesANDACurrent
51655-246GABAPENTINGABAPENTINNorthwind PharmaceuticalsANDACurrent
52959-757GabapentinGabapentinH.J. Harkins Company, Inc.ANDACurrent
53002-1423GABAPENTINGABAPENTINRPK Pharmaceuticals, Inc.ANDACurrent
53002-1423GABAPENTINGABAPENTINRPK Pharmaceuticals, Inc.ANDACurrent
53002-1472GABAPENTINGABAPENTINRPK Pharmaceuticals, Inc.ANDACurrent
53002-1472GABAPENTINGABAPENTINRPK Pharmaceuticals, Inc.ANDACurrent
53002-1472GABAPENTINGABAPENTINRPK Pharmaceuticals, Inc.ANDACurrent
53217-241GABAPENTINGABAPENTINAidarex Pharmaceuticals LLCANDACurrent
55700-453GABAPENTINGABAPENTINLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-453GABAPENTINGABAPENTINLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-483GABAPENTINGABAPENTINLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-483GABAPENTINGABAPENTINLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-483GABAPENTINGABAPENTINLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-483GABAPENTINGABAPENTINLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-039GABAPENTINGABAPENTINSt.Mary's Medical Park PharmacyANDACurrent
60760-627GABAPENTINGABAPENTINSt. MaryANDACurrent
61919-411GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-411GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-417GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-660GABAPENTINGABAPENTINDIRECTRXANDACurrent
61919-660GABAPENTINGABAPENTINDIRECTRXANDACurrent
61919-660GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-660GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-660GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-660GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-982GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-982GABAPENTINGABAPENTINDIRECT RXANDACurrent
63187-031GabapentinGabapentinProficient Rx LPANDACurrent
63187-031GabapentinGabapentinProficient Rx LPANDACurrent
63187-031GabapentinGabapentinProficient Rx LPANDACurrent
63187-056GabapentinGabapentinProficient Rx LPANDACurrent
63187-056GabapentinGabapentinProficient Rx LPANDACurrent
63187-056GabapentinGabapentinProficient Rx LPANDACurrent
63187-248GabapentinGabapentinProficient Rx LPANDACurrent
63187-248GabapentinGabapentinProficient Rx LPANDACurrent
63187-248GabapentinGabapentinProficient Rx LPANDACurrent
63187-372GABAPENTINGABAPENTINProficient Rx LPANDACurrent
63187-372GABAPENTINGABAPENTINProficient Rx LPANDACurrent
63187-392GABAPENTINGABAPENTINProficient Rx LPANDACurrent
63187-392GABAPENTINGABAPENTINProficient Rx LPANDACurrent
63187-909GABAPENTINGABAPENTINProficient Rx LPANDACurrent
63187-909GABAPENTINGABAPENTINProficient Rx LPANDACurrent
63629-2593GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-3056GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-3056GabapentinGabapentinBryant Ranch PrepackANDACurrent
64205-222GabapentinGabapentinReadyMedsANDACurrent
64725-0221GabapentinGabapentinTYA PharmaceuticalsANDACurrent
64725-0222GabapentinGabapentinTYA PharmaceuticalsANDACurrent
67296-1536GABAPENTINGABAPENTINRedPharm Drug, Inc.ANDACurrent
67296-1536GABAPENTINGABAPENTINRedPharm Drug, Inc.ANDACurrent
67296-1536GABAPENTINGABAPENTINRedPharm Drug, Inc.ANDACurrent
67296-1710GABAPENTINGABAPENTINRedPharm Drug, Inc.ANDACurrent
67296-1710GABAPENTINGABAPENTINRedPharm Drug, Inc.ANDACurrent
67296-1721GABAPENTINGABAPENTINRedPharm Drug, Inc.ANDACurrent
67296-1721GABAPENTINGABAPENTINRedPharm Drug, Inc.ANDACurrent
68071-1212GABAPENTINGABAPENTINNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1212GABAPENTINGABAPENTINNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1808GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1907GABAPENTINGABAPENTINNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3086GABAPENTINGABAPENTINNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3086GABAPENTINGABAPENTINNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3086GABAPENTINGABAPENTINNuCare Pharmaceuticals, Inc.ANDACurrent