FDA.reportPublic FDA data

Application 040643

Type
ANDA
Sponsor
VINTAGE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDESYRUP;ORAL6.25MG/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A040643-001PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA2006-04-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040643-001AA

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A040643-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA2006-04-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040643-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA2006-04-26cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040643-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA2006-04-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A040643-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A040643-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040643-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040643-001AA131067a03dcf5…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040643-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040643-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040643-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040643-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040643-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040643-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040643-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040643-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040643-001AA18869cabd3fbd…
2019-12-14 00:12 UTC2019-12A040643-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040643-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040643-001AA1ea99ee380514…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040643-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040643-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040643-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040643-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040643-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040643-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040643-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040643-001AA1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040643-001AA1a50c72e98297…

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
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma7a186bcd-ab8c-4695-8289-4cd33bb551cf2025-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040643
application number: ANDA040643

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0927Promethazine HydrochloridePromethazine HydrochloridePharmaceutical Associates, Inc.ANDACurrent
0121-0927Promethazine HydrochloridePromethazine HydrochloridePharmaceutical Associates, Inc.ANDACurrent
0121-0927Promethazine HydrochloridePromethazine HydrochloridePharmaceutical Associates, Inc.ANDACurrent
0121-0927Promethazine HydrochloridePromethazine HydrochloridePharmaceutical Associates, Inc.ANDACurrent
0603-1584Promethazine HydrochloridePromethazine HydrochloridePar PharmaceuticalANDACurrent
0603-1584Promethazine HydrochloridePromethazine HydrochloridePar PharmaceuticalANDACurrent
50090-0222Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
55045-1643Promethazine HydrochloridePromethazine HydrochlorideDispensing Solutions, Inc.ANDACurrent
68071-1767Promethazine HydrochloridePromethazine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4137Promethazine HydrochloridePromethazine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68151-1584Promethazine HydrochloridePromethazine HydrochlorideCarilion Materials ManagementANDACurrent
68788-7028Promethazine HydrochloridePromethazine HydrochloridePreferred Pharmaceutical Inc.ANDACurrent
68788-7028Promethazine HydrochloridePromethazine HydrochloridePreferred Pharmaceutical Inc.ANDACurrent
68788-8162Promethazine HydrochloridePromethazine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44193ORIG2006-05-03