Application 018810

Type
NDA
Sponsor
THEPHARMANETWORK LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001THERMAZENESILVER SULFADIAZINECREAM;TOPICAL1%NoNo

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

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
N018810-001THERMAZENESILVER SULFADIAZINE1%CREAM / TOPICALAB1985-12-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018810-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-2387673890dc5c…
2021-03-12 10:30 UTC2021-03N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-233f01610625f2…
2019-09-15 20:21 UTC2019-09N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23b00525d2431f…
2019-07-19 19:46 UTC2019-07N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-233f0d92c62455…
2023-05-13 08:27 UTC2023-05N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23053a50430f4f…
2023-01-26 05:58 UTC2023-01N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018810-001THERMAZENE1%CREAM / TOPICALAB1985-12-23cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N018810-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018810-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018810-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018810-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018810-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018810-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018810-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018810-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018810-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018810-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018810-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018810-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018810-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018810-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018810-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018810-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018810-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018810-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018810-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018810-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018810-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N018810-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018810-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018810-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018810-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N018810-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018810-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018810-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018810-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018810-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018810-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018810-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018810-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018810-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018810-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018810-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018810-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018810-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018810-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018810-001AB1cb3db0bc1861…

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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Silver sulfadiazineSILVER SULFADIAZINEAscend Laboratories, LLCb4d6694f-2b0a-4d64-9e05-2fef6d8e60d92026-07-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
ndc (product): 67877-124
Thermazene Silver SulfadiazineSILVER SULFADIAZINEPreferred Pharmaceuticals, Inc.42c3ece4-0df0-4ed8-ac0f-a65fad19eed72026-02-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
ndc (product): 68788-0600
Silver SulfadiazineSILVER SULFADIAZINEAsclemed USA, Inc.4d9aa72e-b8dc-4ea3-be44-80f03ba819822026-01-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
Silver SulfadiazineSILVER SULFADIAZINEA-S Medication Solutions72ca5cb5-14d2-45e4-8b53-ed5809b0aeca2025-12-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
ndc (product): 50090-0607
Silver SulfadiazineSILVER SULFADIAZINEA-S Medication Solutions067895f9-a797-4cbd-a3d2-d611d512fe5b2025-06-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
ndc (product): 50090-0717
Silver SulfadiazineSILVER SULFADIAZINEBryant Ranch Prepack0084786a-09a3-4612-9afc-6733cc0cc56a2025-02-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
ndc (product): 63629-8773
Silver SulfadiazineSILVER SULFADIAZINEAdvanced Rx Pharmacy of Tennessee, LLCf1a0f489-0d9e-66c4-e053-2a95a90a063d2024-12-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
Silver SulfadiazineSILVER SULFADIAZINEA-S Medication Solutionsa4051ae4-f1ef-4082-920f-97d176b4cef22024-11-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
ndc (product): 50090-0763
Silver SulfadiazineSILVER SULFADIAZINEBryant Ranch Prepackede72069-2bb3-43e8-a45c-33ae3efeb9222024-10-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
ndc (product): 63629-8769
Silver SulfadiazineSILVER SULFADIAZINEBryant Ranch Prepackd02fe8b9-2a20-40e7-8674-19768ff4d42d2024-10-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
ndc (product): 63629-8768
Silver SulfadiazineSILVER SULFADIAZINEBryant Ranch Prepack3a04ce6d-4c38-4e21-8273-98a43d8c63592024-10-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
ndc (product): 63629-8772
Silver SulfadiazineSILVER SULFADIAZINEBryant Ranch Prepackb3c0884b-2f6b-4608-9cab-bef2b370bc332024-10-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
ndc (product): 63629-8770
Silver SulfadiazineSILVER SULFADIAZINEBryant Ranch Prepack3604ed05-8d91-475a-b950-2c114b3f890d2024-08-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
ndc (product): 63629-8771
Silver SulfadiazineSILVER SULFADIAZINEProficient Rx LP532d776e-54b3-4d4f-bb7a-94927bfba4d22024-03-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
ndc (product): 63187-023
Silver SulfadiazineSILVER SULFADIAZINEA-S Medication Solutions475953ba-b555-474c-9bcd-8cd314cc0d1f2024-01-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 018810
application number: NDA018810
ndc (product): 50090-2152

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 61 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-0124Silver SulfadiazineSilver SulfadiazineLiberty Pharmaceuticals, Inc.NDACurrent
21695-182ThermazeneSilver SulfadiazineRebel Distributors CorpNDACurrent
33261-589Silver SulfadiazineSilver SulfadiazineAidarex Pharmaceuticals LLCNDACurrent
45865-642Silver SulfadiazineSilver SulfadiazineMedsource PharmaceuticalsNDACurrent
50090-0607Silver SulfadiazineSilver SulfadiazineA-S Medication SolutionsNDACurrent
50090-0607Silver SulfadiazineSilver SulfadiazineA-S Medication SolutionsNDACurrent
50090-0717Silver SulfadiazineSilver SulfadiazineA-S Medication SolutionsNDACurrent
50090-0717Silver SulfadiazineSilver SulfadiazineA-S Medication SolutionsNDACurrent
50090-0717Silver SulfadiazineSilver SulfadiazineA-S Medication SolutionsNDACurrent
50090-0763Silver SulfadiazineSilver SulfadiazineA-S Medication SolutionsNDACurrent
50090-0763Silver SulfadiazineSilver SulfadiazineA-S Medication SolutionsNDACurrent
50090-0763Silver SulfadiazineSilver SulfadiazineA-S Medication SolutionsNDACurrent
50090-2152Silver SulfadiazineSilver SulfadiazineA-S Medication SolutionsNDACurrent
50090-2152Silver SulfadiazineSilver SulfadiazineA-S Medication SolutionsNDACurrent
50436-1240Silver SulfadiazineSilver SulfadiazineUnit Dose ServicesNDACurrent
53002-9090Silver SulfadiazineSilver SulfadiazineRPK Pharmaceuticals, Inc.NDACurrent
53002-9090Silver SulfadiazineSilver SulfadiazineRPK Pharmaceuticals, Inc.NDACurrent
53097-101ThermazeneSilver SulfadiazineThe Pharma Network LLCNDACurrent
55700-068Silver SulfadiazineSilver SulfadiazineLake Erie Medical DBA Quality Care Products LLCNDACurrent
61919-206SILVER SULFADIAZINESILVER SULFADAZINEDIRECT RXNDACurrent
63187-023Silver SulfadiazineSilver SulfadiazineProficient Rx LPNDACurrent
63187-023Silver SulfadiazineSilver SulfadiazineProficient Rx LPNDACurrent
63187-023Silver SulfadiazineSilver SulfadiazineProficient Rx LPNDACurrent
63187-023Silver SulfadiazineSilver SulfadiazineProficient Rx LPNDACurrent
63629-8768Silver SulfadiazineSilver SulfadiazineBryant Ranch PrepackNDACurrent
63629-8768Silver SulfadiazineSilver SulfadiazineBryant Ranch PrepackNDACurrent
63629-8769Silver SulfadiazineSilver SulfadiazineBryant Ranch PrepackNDACurrent
63629-8769Silver SulfadiazineSilver SulfadiazineBryant Ranch PrepackNDACurrent
63629-8770Silver SulfadiazineSilver SulfadiazineBryant Ranch PrepackNDACurrent
63629-8770Silver SulfadiazineSilver SulfadiazineBryant Ranch PrepackNDACurrent
63629-8771Silver SulfadiazineSilver SulfadiazineBryant Ranch PrepackNDACurrent
63629-8771Silver SulfadiazineSilver SulfadiazineBryant Ranch PrepackNDACurrent
63629-8772Silver SulfadiazineSilver SulfadiazineBryant Ranch PrepackNDACurrent
63629-8772Silver SulfadiazineSilver SulfadiazineBryant Ranch PrepackNDACurrent
63629-8773Silver SulfadiazineSilver SulfadiazineBryant Ranch PrepackNDACurrent
63629-8773Silver SulfadiazineSilver SulfadiazineBryant Ranch PrepackNDACurrent
66267-943Silver SulfadiazineSilver SulfadiazineNuCare Pharmaceuticals,Inc.NDACurrent
66267-943Silver SulfadiazineSilver SulfadiazineNuCare Pharmaceuticals,Inc.NDACurrent
66267-943Silver SulfadiazineSilver SulfadiazineNuCare Pharmaceuticals,Inc.NDACurrent
66267-943Silver SulfadiazineSilver SulfadiazineNuCare Pharmaceuticals,Inc.NDACurrent
67877-124Silver SulfadiazineSilver SulfadiazineAscend Laboratories, LLCNDACurrent
67877-124Silver SulfadiazineSilver SulfadiazineAscend Laboratories, LLCNDACurrent
68071-1333Silver SulfadiazineSilver SulfadiazineNuCare Pharmaceuticals,Inc.NDACurrent
68071-1333Silver SulfadiazineSilver SulfadiazineNuCare Pharmaceuticals,Inc.NDACurrent
68071-1334Silver SulfadiazineSilver SulfadiazineNuCare Pharmaceuticals,Inc.NDACurrent
68071-4481Silver SulfadiazineSilver SulfadiazineNuCare Pharmaceuticals,Inc.NDACurrent
68071-4481Silver SulfadiazineSilver SulfadiazineNuCare Pharmaceuticals,Inc.NDACurrent
68788-0600ThermazeneSilver SulfadiazinePreferred Pharmaceuticals, Inc.NDACurrent
68788-0600ThermazeneSilver SulfadiazinePreferred Pharmaceuticals, Inc.NDACurrent
68788-0600ThermazeneSilver SulfadiazinePreferred Pharmaceuticals, Inc.NDACurrent
68788-0600ThermazeneSilver SulfadiazinePreferred Pharmaceuticals, Inc.NDACurrent
68788-9818ThermazeneSilver SulfadiazinePreferred Pharmaceuticals, IncNDACurrent
70518-0366Silver SulfadiazineSilver SulfadiazineREMEDYREPACK INC.NDACurrent
70518-0366Silver SulfadiazineSilver SulfadiazineREMEDYREPACK INC.NDACurrent
70518-0366Silver SulfadiazineSilver SulfadiazineREMEDYREPACK INC.NDACurrent
70518-1562Silver SulfadiazineSilver SulfadiazineREMEDYREPACK INC.NDACurrent
70518-1562Silver SulfadiazineSilver SulfadiazineREMEDYREPACK INC.NDACurrent
70518-1562Silver SulfadiazineSilver SulfadiazineREMEDYREPACK INC.NDACurrent
70518-1562Silver SulfadiazineSilver SulfadiazineREMEDYREPACK INC.NDACurrent
70518-1562Silver SulfadiazineSilver SulfadiazineREMEDYREPACK INC.NDACurrent
8880-9505ThermazeneSilver SulfadiazineCOVIDIEN INC.NDACurrent