Application 215997

Type
ANDA
Sponsor
SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL3.125MG;3.125MG;3.125MG;3.125MGNoNo
002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL6.25MG;6.25MG;6.25MG;6.25MGNoNo
003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL9.375MG;9.375MG;9.375MG;9.375MGNoNo
004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL12.5MG;12.5MG;12.5MG;12.5MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215997-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE3.125MG;3.125MG;3.125MG;3.125MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-27
A215997-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-27
A215997-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE9.375MG;9.375MG;9.375MG;9.375MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-27
A215997-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE12.5MG;12.5MG;12.5MG;12.5MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A215997-001AB2
A215997-002AB2
A215997-003AB2
A215997-004AB2

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 3 · 92 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215997-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215997-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215997-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE9.375MG;9.375MG;9.375MG;9.375MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215997-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE12.5MG;12.5MG;12.5MG;12.5MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215997-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215997-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215997-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE9.375MG;9.375MG;9.375MG;9.375MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215997-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE12.5MG;12.5MG;12.5MG;12.5MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215997-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A215997-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A215997-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE9.375MG;9.375MG;9.375MG;9.375MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A215997-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE12.5MG;12.5MG;12.5MG;12.5MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215997-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215997-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215997-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE9.375MG;9.375MG;9.375MG;9.375MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215997-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE12.5MG;12.5MG;12.5MG;12.5MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215997-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215997-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215997-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE9.375MG;9.375MG;9.375MG;9.375MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215997-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE12.5MG;12.5MG;12.5MG;12.5MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215997-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215997-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215997-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE9.375MG;9.375MG;9.375MG;9.375MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215997-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE12.5MG;12.5MG;12.5MG;12.5MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215997-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215997-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215997-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE9.375MG;9.375MG;9.375MG;9.375MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215997-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE12.5MG;12.5MG;12.5MG;12.5MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-278072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215997-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-276a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215997-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-276a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215997-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE9.375MG;9.375MG;9.375MG;9.375MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-276a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215997-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE12.5MG;12.5MG;12.5MG;12.5MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215997-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-271c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215997-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-271c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215997-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE9.375MG;9.375MG;9.375MG;9.375MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-271c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215997-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE12.5MG;12.5MG;12.5MG;12.5MGCAPSULE, EXTENDED RELEASE / ORALAB22023-09-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215997-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGCAPSULE, EXTENDED RELEASE / ORALAB2023-09-27ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A215997-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORALAB2023-09-27ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A215997-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE9.375MG;9.375MG;9.375MG;9.375MGCAPSULE, EXTENDED RELEASE / ORALAB2023-09-27ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A215997-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE12.5MG;12.5MG;12.5MG;12.5MGCAPSULE, EXTENDED RELEASE / ORALAB2023-09-27ea1830bbd6c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 92 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A215997-001AB21c2088c7a36db…
2026-10-15 13:18:302026-09A215997-002AB21c2088c7a36db…
2026-10-15 13:18:302026-09A215997-003AB21c2088c7a36db…
2026-10-15 13:18:302026-09A215997-004AB21c2088c7a36db…
2026-09-14 22:38:342026-08A215997-001AB2184e616aacf4f…
2026-09-14 22:38:342026-08A215997-002AB2184e616aacf4f…
2026-09-14 22:38:342026-08A215997-003AB2184e616aacf4f…
2026-09-14 22:38:342026-08A215997-004AB2184e616aacf4f…
2026-08-18 06:07:402026-07A215997-001AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A215997-002AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A215997-003AB21caaa826d4ba7…
2026-08-18 06:07:402026-07A215997-004AB21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215997-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215997-002AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215997-003AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215997-004AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215997-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215997-002AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215997-003AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215997-004AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215997-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215997-002AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215997-003AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215997-004AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215997-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215997-002AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215997-003AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215997-004AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215997-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215997-002AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215997-003AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215997-004AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215997-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215997-002AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215997-003AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215997-004AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215997-001AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215997-002AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215997-003AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215997-004AB212680178bc6a6…

Reported adverse events (FAERS/openFDA)#

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