Gabapentin

Product NDC
68788-9023
11-digit product format
687889023
Labeler code
68788
Product ID
68788-9023_892a420a-f473-4b38-b82d-181edc819845
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA077662
Marketing category
ANDA
Marketing start
2006-04-01
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
600 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-9023DDiscontinued by firm2026-08-17
excluded packagepackage68788-902368788-9023-1DDiscontinued by firm2026-08-17
excluded packagepackage68788-902368788-9023-3DDiscontinued by firm2026-08-17
excluded packagepackage68788-902368788-9023-6DDiscontinued by firm2026-08-17
excluded packagepackage68788-902368788-9023-8DDiscontinued by firm2026-08-17
excluded packagepackage68788-902368788-9023-9DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 72 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9023-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9023-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9023-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9023-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9023-8d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9023-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9023-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9023-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9023-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9023-8f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9023-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9023-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9023-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9023-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9023-82ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9023-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9023-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9023-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9023-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9023-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9023-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9023-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9023-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9023-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9023-8cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9023-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9023-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9023-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9023-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9023-8cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9023-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9023-9302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9023-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9023-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9023-8302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9023-6ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9023-9ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9023-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9023-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9023-8ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9023-60efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9023-90efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9023-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9023-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9023-80efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9023-6ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9023-9ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9023-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9023-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9023-8ad56d346431e…cc804d4bbf1e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077662-001GABAPENTINGABAPENTIN600MGTABLET / ORALAB12006-08-18
A077662-002GABAPENTINGABAPENTIN800MGTABLET / ORALAB12006-08-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A077662-001AB1
A077662-002AB1

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18caaa826d4ba7…
2026-08-18 06:07:402026-07A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077662-001GABAPENTIN600MGTABLET / ORALAB2006-08-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077662-002GABAPENTIN800MGTABLET / ORALAB2006-08-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077662-001GABAPENTIN600MGTABLET / ORALAB2006-08-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077662-002GABAPENTIN800MGTABLET / ORALAB2006-08-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077662-001GABAPENTIN600MGTABLET / ORALAB2006-08-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077662-002GABAPENTIN800MGTABLET / ORALAB2006-08-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077662-001GABAPENTIN600MGTABLET / ORALAB2006-08-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077662-002GABAPENTIN800MGTABLET / ORALAB2006-08-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077662-001GABAPENTIN600MGTABLET / ORALAB2006-08-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077662-002GABAPENTIN800MGTABLET / ORALAB2006-08-18bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077662-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A077662-002AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077662-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077662-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077662-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077662-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077662-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077662-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077662-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077662-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077662-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077662-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077662-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077662-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077662-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077662-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077662-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077662-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077662-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077662-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077662-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A077662-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077662-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077662-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077662-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077662-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077662-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077662-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077662-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077662-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077662-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077662-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077662-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077662-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077662-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077662-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077662-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077662-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077662-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077662-002AB1bb7c543d1eb4…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINCoupler LLC583ab038-7b6e-96f8-e063-6294a90adf472026-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINUnit Dose Solutions, Inc.54edd6f3-06c7-a0c7-e063-6394a90a8b4f2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINBryant Ranch Prepack4cb26d6e-7963-4fe5-903e-ab51805450662026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINBluePoint Laboratories3368bf70-d466-4765-b2b7-7fe967a8c2b72026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINBryant Ranch Prepack632cb507-5675-2392-0460-b09c0dd146502026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINGlenmark Pharmaceuticals Inc., USA3865a6e3-112c-490c-82ac-35401336b16e2025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINBryant Ranch Prepack137b2b9a-9d42-48d0-913f-5dc146fb689a2025-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINBryant Ranch Prepack2278ce1b-1c19-4ad2-89c6-4530f7b78ea72025-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINPD-Rx Pharmaceuticals, Inc.7c3b232a-3e9f-4249-9e5a-295482ee288a2025-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINProficient Rx LPc78f528f-9192-4037-bfb9-ff5718ed26c52019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662