Application 040526

Type
ANDA
Sponsor
SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDETABLET;ORAL37.5MGNoNo

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
A040526-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040526-001AA

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 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 UTC2026-02A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-233f01610625f2…
2019-09-15 20:21 UTC2019-09A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23cb3db0bc1861…

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 UTC2026-02A040526-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040526-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040526-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040526-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040526-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040526-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040526-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040526-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040526-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040526-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040526-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040526-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040526-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040526-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040526-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040526-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040526-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040526-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040526-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040526-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040526-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040526-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040526-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040526-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040526-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040526-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040526-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040526-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040526-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040526-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040526-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040526-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040526-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040526-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040526-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040526-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040526-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040526-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040526-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040526-001AA1cb3db0bc1861…

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HCL C-IVPHENTERMINE HCL C-IVDirect_Rx4cec0e47-5373-2133-e063-6394a90a20092026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.aa9d7161-cda3-4ded-8d5b-424abd1a66812026-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutions0e893b62-bb07-4984-9f0a-3601435fbc272026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
ndc (product): 50090-1498
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENorthwind Health Company, LLC1b5396a8-e7ef-45ae-e063-6294a90a14a22025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.abf702d6-6f94-48dc-ad23-c52fd74e83a82025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
ndc (product): 43063-596
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEMartek Pharmacal Co.12699287-9ca9-07b3-e063-6294a90af21a2025-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.02b8f684-b1ca-4ab7-9567-bcacc6a927792025-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
ndc (product): 53489-676
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.312d9742-6a65-c1cb-e063-6394a90a2e662025-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.8abf898e-318b-3519-e053-2995a90abf2f2024-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
ndc (product): 68071-4919
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack53cad049-f1b4-42c0-9cc7-a1c2df75ac582024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
ndc (product): 71335-0350
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack0ca26b58-0a93-4a10-be4d-63a4ad5eecf82024-06-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
ndc (product): 63629-1107
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackac8559a0-98fe-4737-b9ec-e36eef3b14fc2024-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
ndc (product): 63629-1106
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackc5d60a6d-2410-4a3c-88e1-a6126b56cf6a2024-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
ndc (product): 63629-1108
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack95f908c2-1003-4e8f-8e4a-86f4934568782024-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
ndc (product): 71335-1312
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack83802088-f4fc-4b34-9268-d63fb2ad16552023-09-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEProficient Rx LPb14a8f6a-a1c6-4104-80f2-0fa35320d04c2023-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 51 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-552Phentermine HydrochloridePhentermine HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
12634-687Phentermine HydrochloridePhentermine HydrochlorideApotheca Inc.ANDACurrent
33358-435Phentermine HydrochloridePhentermine HydrochlorideRxChange Co.ANDACurrent
43063-332Phentermine HydrochloridePhentermine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-596Phentermine HydrochloridePhentermine HydrochloridePD-Rx Pharmaceuticals, InANDACurrent
43063-596Phentermine HydrochloridePhentermine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-596Phentermine HydrochloridePhentermine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-596Phentermine HydrochloridePhentermine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-596Phentermine HydrochloridePhentermine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-596Phentermine HydrochloridePhentermine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-596Phentermine HydrochloridePhentermine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-596Phentermine HydrochloridePhentermine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-596Phentermine HydrochloridePhentermine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-1114Phentermine HydrochloridePhentermine HydrochlorideA-S Medication Solutions LLCANDACurrent
50090-1498Phentermine HydrochloridePhentermine HydrochlorideA-S Medication SolutionsANDACurrent
50090-1498Phentermine HydrochloridePhentermine HydrochlorideA-S Medication SolutionsANDACurrent
50090-1499Phentermine HydrochloridePhentermine HydrochlorideA-S Medication SolutionsANDACurrent
50090-1499Phentermine HydrochloridePhentermine HydrochlorideA-S Medication SolutionsANDACurrent
50436-3173Phentermine HydrochloridePhentermine HydrochlorideUnit Dose ServicesANDACurrent
50436-3173Phentermine HydrochloridePhentermine HydrochlorideUnit Dose ServicesANDACurrent
50436-6745Phentermine HydrochloridePhentermine HydrochlorideUnit Dose ServicesANDACurrent
50436-6760Phentermine HydrochloridePhentermine HydrochlorideUnit Dose ServicesANDACurrent
51655-875Phentermine hydrochloridePhentermine hydrochlorideNorthwind PharmaceuticalsANDACurrent
53217-172Phentermine HydrochloridePhentermine HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
53489-406Phentermine HydrochloridePhentermine HydrochlorideMutual Pharmaceutical Company, Inc.ANDACurrent
53489-676Phentermine HydrochloridePhentermine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
53489-676Phentermine HydrochloridePhentermine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
53489-676Phentermine HydrochloridePhentermine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
63187-144Phentermine HydrochloridePhentermine HydrochlorideProficient Rx LPANDACurrent
63629-1106Phentermine HydrochloridePhentermine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1106Phentermine HydrochloridePhentermine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1106Phentermine HydrochloridePhentermine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1107Phentermine HydrochloridePhentermine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1107Phentermine HydrochloridePhentermine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1107Phentermine HydrochloridePhentermine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1108Phentermine HydrochloridePhentermine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1108Phentermine HydrochloridePhentermine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1108Phentermine HydrochloridePhentermine HydrochlorideBryant Ranch PrepackANDACurrent
66267-166Phentermine HydrochloridePhentermine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-166Phentermine HydrochloridePhentermine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-166Phentermine HydrochloridePhentermine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4919Phentermine HydrochloridePhentermine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4919Phentermine HydrochloridePhentermine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
70934-474Phentermine HydrochloridePhentermine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-474Phentermine HydrochloridePhentermine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0350Phentermine HydrochloridePhentermine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0350Phentermine HydrochloridePhentermine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0350Phentermine HydrochloridePhentermine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0350Phentermine HydrochloridePhentermine HydrochlorideBryant Ranch PrepackANDACurrent
71335-1312Phentermine HydrochloridePhentermine HydrochlorideBryant Ranch PrepackANDACurrent
71335-1312Phentermine HydrochloridePhentermine HydrochlorideBryant Ranch PrepackANDACurrent