Neomycin and Polymyxin B Sulfates and Dexamethasone

Product NDC
26637-941
11-digit product format
266370941
Labeler code
26637
Product ID
26637-941_485333b8-f6ab-4f82-aa26-c2fd845a8f7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone, Neomycin sulfate, Polymysin B sulfate
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Putney, Inc.
Application
ANDA062938
Marketing category
ANDA
Marketing start
2016-02-29
Marketing end
0000-00-00
Substance
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
1 mg/g; mg/g; [USP'U]/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct26637-941DDiscontinued by firm2026-09-09
excluded packagepackage26637-94126637-941-41DDiscontinued by firm2026-09-09

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 1 · 28 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage26637-941-41DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage26637-941-41DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage26637-941-41DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage26637-941-41DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage26637-941-41DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage26637-941-41DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage26637-941-41DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage26637-941-41DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage26637-941-41DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage26637-941-41DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage26637-941-41DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage26637-941-41DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage26637-941-41IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage26637-941-41IInactivated by FDA9bebd1f3094a…5416666fcb17…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEDEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC1989-07-31

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC1989-07-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-313f01610625f2…
2019-09-15 20:21 UTC2019-09A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062938-001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1989-07-31e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A062938-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062938-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062938-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062938-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062938-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062938-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062938-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062938-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062938-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062938-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062938-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062938-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062938-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062938-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062938-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062938-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062938-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062938-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062938-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062938-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062938-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A062938-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062938-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062938-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062938-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A062938-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A062938-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062938-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062938-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062938-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062938-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062938-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062938-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062938-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A062938-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A062938-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062938-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062938-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062938-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062938-001AT1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONEProficient Rx LPbd9f3220-6d42-4863-aa2a-b17b138d095d2021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062938
application number: ANDA062938