Application 202099

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZENATANE	ISOTRETINOIN	CAPSULE;ORAL	10MG	No	No
002	ZENATANE	ISOTRETINOIN	CAPSULE;ORAL	20MG	No	No
003	ZENATANE	ISOTRETINOIN	CAPSULE;ORAL	40MG	No	No
004	ZENATANE	ISOTRETINOIN	CAPSULE;ORAL	30MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202099-001	ZENATANE	ISOTRETINOIN	10MG	CAPSULE / ORAL	AB1	2013-03-25
A202099-002	ZENATANE	ISOTRETINOIN	20MG	CAPSULE / ORAL	AB1	2013-03-25
A202099-003	ZENATANE	ISOTRETINOIN	40MG	CAPSULE / ORAL	AB1	2013-03-25
A202099-004	ZENATANE	ISOTRETINOIN	30MG	CAPSULE / ORAL	AB1	2015-02-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202099-001	AB1
A202099-002	AB1
A202099-003	AB1
A202099-004	AB1

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202099-001	ZENATANE	10MG	CAPSULE / ORAL	AB1	2013-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202099-002	ZENATANE	20MG	CAPSULE / ORAL	AB1	2013-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202099-003	ZENATANE	40MG	CAPSULE / ORAL	AB1	2013-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202099-004	ZENATANE	30MG	CAPSULE / ORAL	AB1	2015-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202099-001	ZENATANE	10MG	CAPSULE / ORAL	AB1	2013-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202099-002	ZENATANE	20MG	CAPSULE / ORAL	AB1	2013-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202099-003	ZENATANE	40MG	CAPSULE / ORAL	AB1	2013-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202099-004	ZENATANE	30MG	CAPSULE / ORAL	AB1	2015-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202099-001	ZENATANE	10MG	CAPSULE / ORAL	AB1	2013-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202099-002	ZENATANE	20MG	CAPSULE / ORAL	AB1	2013-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202099-003	ZENATANE	40MG	CAPSULE / ORAL	AB1	2013-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202099-004	ZENATANE	30MG	CAPSULE / ORAL	AB1	2015-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202099-001	ZENATANE	10MG	CAPSULE / ORAL	AB1	2013-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202099-002	ZENATANE	20MG	CAPSULE / ORAL	AB1	2013-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202099-003	ZENATANE	40MG	CAPSULE / ORAL	AB1	2013-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202099-004	ZENATANE	30MG	CAPSULE / ORAL	AB1	2015-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202099-001	ZENATANE	10MG	CAPSULE / ORAL	AB1	2013-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202099-002	ZENATANE	20MG	CAPSULE / ORAL	AB1	2013-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202099-003	ZENATANE	40MG	CAPSULE / ORAL	AB1	2013-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202099-004	ZENATANE	30MG	CAPSULE / ORAL	AB1	2015-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202099-001	ZENATANE	10MG	CAPSULE / ORAL	AB1	2013-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202099-002	ZENATANE	20MG	CAPSULE / ORAL	AB1	2013-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202099-003	ZENATANE	40MG	CAPSULE / ORAL	AB1	2013-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202099-004	ZENATANE	30MG	CAPSULE / ORAL	AB1	2015-02-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202099-001	ZENATANE	10MG	CAPSULE / ORAL	AB1	2013-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202099-002	ZENATANE	20MG	CAPSULE / ORAL	AB1	2013-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202099-003	ZENATANE	40MG	CAPSULE / ORAL	AB1	2013-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202099-004	ZENATANE	30MG	CAPSULE / ORAL	AB1	2015-02-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202099-001	ZENATANE	10MG	CAPSULE / ORAL	AB1	2013-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202099-002	ZENATANE	20MG	CAPSULE / ORAL	AB1	2013-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202099-003	ZENATANE	40MG	CAPSULE / ORAL	AB1	2013-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202099-004	ZENATANE	30MG	CAPSULE / ORAL	AB1	2015-02-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202099-001	ZENATANE	10MG	CAPSULE / ORAL	AB1	2013-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202099-002	ZENATANE	20MG	CAPSULE / ORAL	AB1	2013-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202099-003	ZENATANE	40MG	CAPSULE / ORAL	AB1	2013-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202099-004	ZENATANE	30MG	CAPSULE / ORAL	AB1	2015-02-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202099-001	ZENATANE	10MG	CAPSULE / ORAL	AB1	2013-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202099-002	ZENATANE	20MG	CAPSULE / ORAL	AB1	2013-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202099-003	ZENATANE	40MG	CAPSULE / ORAL	AB1	2013-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202099-004	ZENATANE	30MG	CAPSULE / ORAL	AB1	2015-02-23	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202099-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202099-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202099-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202099-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202099-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202099-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202099-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202099-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202099-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202099-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202099-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202099-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202099-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202099-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202099-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202099-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202099-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202099-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202099-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202099-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202099-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202099-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202099-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202099-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202099-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202099-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202099-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202099-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202099-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202099-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202099-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202099-004	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202099-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202099-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202099-003	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202099-004	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202099-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202099-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202099-003	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202099-004	AB1	1	`d06236e962d9…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZENATANE	ISOTRETINOIN	BluePoint Laboratories	486d4a4b-0de5-431a-bef7-dae6b0e4fa20	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202099 application number: ANDA202099
ACCUTANE	ISOTRETINOIN	JG Pharma Inc.	5b524a51-a16b-496e-b764-11c98c479c36	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202099 application number: ANDA202099 ndc (product): 72143-254 ndc (product): 72143-252 ndc (product): 72143-251 ndc (product): 72143-253
ZENATANE	ISOTRETINOIN	Dr. Reddy's Laboratories Limited	27b3cf26-f22e-5b70-1c24-009933b7c6ee	2025-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202099 application number: ANDA202099 ndc (product): 55111-137 ndc (product): 55111-136 ndc (product): 55111-113 ndc (product): 55111-135

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55111-113	ZENATANE	ISOTRETINOIN	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-113	ZENATANE	ISOTRETINOIN	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-113	ZENATANE	ISOTRETINOIN	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-113	ZENATANE	ISOTRETINOIN	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-113	ZENATANE	ISOTRETINOIN	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-135	ZENATANE	ISOTRETINOIN	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-135	ZENATANE	ISOTRETINOIN	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-135	ZENATANE	ISOTRETINOIN	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-135	ZENATANE	ISOTRETINOIN	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-135	ZENATANE	ISOTRETINOIN	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-136	ZENATANE	ISOTRETINOIN	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-136	ZENATANE	ISOTRETINOIN	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-136	ZENATANE	ISOTRETINOIN	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-136	ZENATANE	ISOTRETINOIN	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-136	ZENATANE	ISOTRETINOIN	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-137	ZENATANE	ISOTRETINOIN	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-137	ZENATANE	ISOTRETINOIN	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-137	ZENATANE	ISOTRETINOIN	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-137	ZENATANE	ISOTRETINOIN	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-137	ZENATANE	ISOTRETINOIN	Dr. Reddy's Laboratories Limited	ANDA	Current
72143-231	ACCUTANE	ISOTRETINOIN	JG Pharma Inc.	ANDA	Current
72143-231	ACCUTANE	ISOTRETINOIN	JG Pharma Inc.	ANDA	Current
72143-232	ACCUTANE	ISOTRETINOIN	JG Pharma Inc.	ANDA	Current
72143-232	ACCUTANE	ISOTRETINOIN	JG Pharma Inc.	ANDA	Current
72143-233	ACCUTANE	ISOTRETINOIN	JG Pharma Inc.	ANDA	Current
72143-233	ACCUTANE	ISOTRETINOIN	JG Pharma Inc.	ANDA	Current
72143-234	ACCUTANE	ISOTRETINOIN	JG Pharma Inc.	ANDA	Current
72143-234	ACCUTANE	ISOTRETINOIN	JG Pharma Inc.	ANDA	Current
72143-251	ACCUTANE	ISOTRETINOIN	JG Pharma Inc.	ANDA	Current
72143-252	ACCUTANE	ISOTRETINOIN	JG Pharma Inc.	ANDA	Current
72143-253	ACCUTANE	ISOTRETINOIN	JG Pharma Inc.	ANDA	Current
72143-254	ACCUTANE	ISOTRETINOIN	JG Pharma Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44577	ORIG	2015-07-02